MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000-1-HAND 10X12CM; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4008

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Event Description

It was reported that the film was low adhesive.There was no impact to the patient reported.A back-up dressing was available to be used.

Manufacturer Narrative

We have concluded our investigation into this complaint.A device history record review was carried out for lot 1804 supplied.This confirmed that the product had been manufactured in accordance with defined procedures and specifications.There was no record of any problems or deviations occurring during the manufacturing of this product in relation to the reported issue.A product evaluation carried out on 6 returned samples for lot 1804.4 of 6 samples confirmed the reported failure.Both failure modes were reviewed for this complaint.No evidence of ¿twisted packaging¿ was found, however the backing paper of the dressing was found to appear creased.Returned samples showed signs of delamination between the film layer and the liner paper.This is an intermittent defect which occurs during the manufacture and construction of the final dressing.Work is ongoing internally on the manufacturing process to try and resolve the issue.Smith & nephew acknowledge customer concern and are continually investigation ways to develop and improve our product.We will continue to monitor for adverse trends relating to this product range.

• Brand Name: IV3000-1-HAND 10X12CM
• 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: 8468035
• MDR Text Key: 140441538
• Report Number: 8043484-2019-00217
• Device Sequence Number: 1
• Product Code: KGX
• 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: 06/24/2019

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: 4008
• Device Lot Number: 1804
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/31/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1