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03 Sep 2019

CLH Blog - MHRA Field Safety Updates For August 2019

CLH Blog - MHRA Field Safety Updates For August 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.

 

Concerto & Basic Shower Trolley - Field Safety Alert

Potential unintentional drop of safety side panel. Each Concerto & Basic shower trolley is equipped with two Side Supports, one on each side of the shower trolley (Image 1). Each side support is secured by two (2) Safety Catches (Image 2) which are used to fold down the supports as well as secure the support in the raised position.

Affected Product: Concerto & Basic shower trolleys manufactured between November 2018 and June 2019; Serial number ranges: P0512263 to P0551621

Concerto & Basic shower trolleys fitted with the affected spare parts (safety catch) part no. 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031 S8542201-014, S8523559-031, 100-805-03, 100-806-03 during service between 2019-Nov-27 and 2019-Jun-14.

FSN date: August 2019

 

LBgard® Blood Collection Tube - Field Safety Alert

Description of the problem:

A review of all data reports referenced in the Technical File for LBgard, along with data from additional studies performed after the CE Mark was attained, was performed as part of a post-acquisition integration.  The following performance indicators were not supported by the data: Product shelf life at 14 months and sample stability at 14 days. As a result, the Instructions for Use (IFU) and the label claims for LBgard will be modified as noted in the chart below.  

A risk assessment was performed to evaluate the potential hazard to patients associated with the precollection and post-collection stability of the LBgard as it pertains to cell-free DNA. LBgard is designed to stabilize DNA in blood samples for downstream use in in vitro diagnostic (IVD) tests as validated by the test provider. LBgard is not designed or validated by Biomatrica to generate results from IVD tests. The product does not have any direct contact with patients, therefore, only indirect hazard was identified, and
the greatest indirect hazard for LBgard is potential deterioration of product performance (including reduction in shelf life and sample stability).

Based on the new product specifications, the following is a list of lots that are expired:

Lot Number: Current Expiration Date (14-month shelf life) Revised Expiration Date (9-month shelf life)
A1710353 Dec-18 NA – product is expired
A18043A5 Jun-19 Jan-19 – product is expired 

FSN date: August 2019

 

Breas Medical - Nippy - Field Safety Alert

Devices affected by FSN 021_19

Breathing circuits supplied for use with the NIPPY range of ventilators as detailed below:

Code Item:

3505 Flexible catheter mount, 22F with swivel elbow and double flip top cap
0792/SP1 NIPPY Dry 22mm Breathing Circuit for Tracheotomy with Bacterial Filter
0793/SP1 NIPPY Dry 22mm Breathing Circuit for Tracheotomy IPPV Mode
0794/SP7 NIPPY Dry Breathing Circuit 22mm Smoothbore with 0681 HME & Purple port
0794/SP7v1 NIPPY Dry Breathing Circuit 22mm Smoothbore with 0681 HME
0794/SP10 NIPPY Dry 22mm Circuit
0805/SP1 NIPPY Heated Circuit for Tracheotomy - for Fisher & Paykel 85...
0805/SP6 NIPPY Heated Circuit for Tracheotomy - for Fisher & Paykel 85...
0814 0814 NIPPY Heated Circuit for IPPV mode

Affected circuits were manufactured in the date range:

Between 22/3/2018 and 24/07/2019

Intersurgical Ltd who manufacture the catheter mount (part no 3505000) used on the above NIPPY circuits have issued an urgent recall notice. (copy attached to this e-mail notification for your information).

Intersurgical have received complaints about cracked ports in the swivel elbow where the flip cap is inserted, and these cracks leak if they reach a significant size. The percentage of cracked products in any lot may vary between 0% and approximately 10%. The cracks were not present at the time of manufacture but have occurred later on during storage.

FSN date: August 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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