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05 Mar 2019

CLH Blog - MHRA Field Safety Updates For February 2019

CLH Blog - MHRA Field Safety Updates For February 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Accu-Chek Insight insulin pumps - Roche Diabetes Care - Field Safety Alert

The key lock function of the affected pumps (pumps with serial numbers below 32100000) lock only the buttons on the front of the insulin pump. It does not lock the quick bolus keys on the top.

Some of the pumps need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons. Roche Diabetes Care issued important instruction on how to fit two separate key frames onto all affected pumps as they received reports of unintended boluses being delivered.

FSN Date: February 2019

Paracetamol 10mg/ml Solution for Infusion - Accord Healthcare Limited -  Field Safety Alert

There is an error on the portion of the Patient Information Leaflet (PIL) for the above product which is intended for Healthcare Professionals. The PIL for Paracetamol 10mg/ml Solution for Infusion is a joint PIL between the 50ml vial and the 100ml vial. The error applies to the 50ml vial, which is not currently marketed. The 100ml vial is restricted for use in adults, adolescents and children weighing more than 33kg but we cannot rule out the possibility that it is being used for the treatment of term newborn infants, infants, toddlers and children weighing 33kg or less. All unexpired batches of the product currently on the market supplied by both Marketing Authorisation holders listed above are within scope.

In the incorrect version of the PIL, the maximum volume of solution for administration to babies and infants weighing 10kg or less is given as 75ml on the dosage table intended for Healthcare professionals. The correct maximum volume for administration to this group is 7.5ml, however.

The PIL has already been corrected and can be accessed via the following link:
https://www.medicines.org.uk/emc/product/2972/pil

FSN Date: February 2019

Rectal Tubes, Unoversal Drainage Systems, SimpaVac, Sterile Suction Connecting Tubes, Sterile Connecting Pieces, Suction Handles/Sets (FilterFlow™/Deltaflo), Oxygen Catheters, Sterile Nasal Oxygen Cannulas, Sterile Oxygen ConnectingTubes, and Sterile Forceps - ConvaTec - Urgent Field Safety Notice

Description of the problem:

ConvaTec has voluntarily initiated a recall of specific product codes of the above-mentioned products. Internal assessment of product packaging integrity has confirmed that these devices are not meeting our expectations or those of our customers. Transportation testing conducted on the product packaging failed confirming the potential for a breach in the sterile barrier. Using a non-sterile device on a patient may expose the patient to infectious agents increasing the patient risk of developing infection. ConvaTec has not received any reports of incidents related to the packaging seal issue.

Product Descriptions:

  • Rectal Tubes are single-use devices which are inserted via the rectum to drain faeces, perform lavage, administer medicine and/or enemas to the lower intestine, for colonoscopy exploration and colonic decompression.
  • Universal Drainage Systems are intended to be used for wound drainage by means of low vacuum where a medium or small volume of post-operative bleeding is expected. They are single use devices that are intended for use in short-term treatment.
  • SimpaVac is a canister intended for low vacuum post-operative wound drainage in conventional (open) surgery.
  • Sterile Suction Connecting Tubes are intended to connect two existing devices, (e.g. suction handles and canisters), or as an extension between an existing device and a vacuum source.
  • Sterile Connecting Pieces are intended to connect two existing devices such as suction handles and collection canisters.
  • Suction Handle/Sets (FilterFlow™/Deltaflo) is a device intended primarily for orthopaedic surgical procedures to remove and collect debris and bone fragments chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.
  • Oxygen Catheters are single patient use devices, requiring short-term oxygen therapy and administer oxygen (in low concentration) directly via the nasopharyngeal or nasal route.
  • Sterile Nasal Oxygen Cannulas are intended for direct administration of low concentrations of oxygen via the bi-nasal route.
  • Sterile Oxygen Connecting Tubes are intended for administration of low/medium concentration of oxygen in oxygen therapy. The connecting/extension tubes channel the oxygen from a stationary or mobile oxygen supply unit to the patient via a dispensing device. Dispensing devices can be e.g. oxygen catheters, nasal oxygen cannulas or facemasks. When using connecting/extension tubes between the patient dispensing device and the supply unit, the patient is allowed more freedom of movement without interruption of the oxygen flow.
  • Sterile Forceps: These are single use tweezers for multiple applications. Used in clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. 

FSN Date: February 2019

Orthopaedic implant rHead Radial Head and Uni-Elbow - Stryker - Urgent Field Safety Alert

Problem:

Stryker issued a Field Safety Notice dated November 2017 informing clinicians of the recall of the rHead Radial Head and Uni-Elbow prosthesis. The manufacturer identifies the possibility of post-operative implant loosening (septic and aseptic), instability (moderate/severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement, heterotopic ossification with these devices.

Device details:

All lots of the Stryker rHead Radial Head and Uni-Elbow are affected.

FSN Date: February 2019

As always, we’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroupLtd to let us know and don’t forget to use '#CommittedToCare' in your posts.

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