MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. LEUKOSTRIP 13X102MM CTN 50; TOPICAL APPROXIMATION SYSTEM

Model Number 66002880

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that, during set up or inspection before use, it was confirmed there was a foreign substance in the sterile pouch.A backup was available to complete the procedure.It is unknown if there was a delay.No injury or other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the product has been returned and evaluated, the event is confirmed.Visual inspection of the dressing has confirmed the reported contamination, this has been confirmed to be additional adhesive, this is not any other form of contamination.A documentation review has revealed previously cases with a similar nature, there are no open corrective actions.The manufacturing records confirm the device met the final product specifications and contain no contributory factors to the reported event, a review of the manufacturing process has revealed the probable root cause.The associated risk files mitigate this event type.A probable root cause is related to training, the contamination, is additional adhesive, which can be found on the raw material.This, once located should be picked out preventing this from reaching the product market.Retraining has been conducted to reduce the probability of future occurrences.No corrective actions are deemed necessary, at this stage, smith and nephew will continue to monitor for adverse trends relating to the reported event.

• Brand Name: LEUKOSTRIP 13X102MM CTN 50
• Type of Device: TOPICAL APPROXIMATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14191044
• MDR Text Key: 289958956
• Report Number: 8043484-2022-00125
• Device Sequence Number: 1
• Product Code: MZR
• UDI-Device Identifier: 05000223449186
• UDI-Public: 05000223449186
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 66002880
• Device Catalogue Number: 66002880
• Device Lot Number: 2119A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1