MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number 59410882

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Event Description

It was reported that when the customer removed the carrier#2 of the iv3000 dressing, the film dressing adhered to the carrier#2 and peeled off from the frame, so it was impossible to use.A backup was available.No delay was reported.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review was carried out using the lot and part numbers provided, there have been further complaints reported with this failure mode in the past three years.The device was intended for use in treatment.It was reported that issues were identified during application.The returned samples were visually and functionally evaluated which confirmed the failure mode of delamination.This confirmed a relationship between the event and the device.Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process.During the manufacturing of the dressing, in process checks are undertaken for this product.All material is manufactured according to the specification and only product meeting the release criteria will be passed on for further processing.The root cause was determined as a manufacturing process issue.As this is failure mode¿s current occurrence rate is within our acceptable range, no further actions are deemed necessary.The relevant manufacturing team will be informed of this complaint.Smith and nephew acknowledges customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 WINDOW FRAME 10X12CM CTN 50
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10317466
• MDR Text Key: 200191112
• Report Number: 8043484-2020-02171
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111151575
• UDI-Public: 4582111151575
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 59410882
• Device Lot Number: 1848
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1