MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4007

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Event Description

It was reported that when the carrier #4 was removed, the film dressing got peeled off from the skin due to the strong adhesion between the film and the carrier #4.No patient harm.No delay.Backup dressings were available.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The batch records were 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 its finished product specification.There was no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.Complaint samples were received and assessed.They were pasted onto the arm and the non adhesive tab at the end of the dressing was lifted to peel the carrier from the dressing.The carrier was hardly separated from the soft film and some of the samples showed carrier delamination and a thin layer left on the film.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The results of the investigation have shown that the most probable cause was an incorrect knife temperature setting.This has now been adjusted and the in process inspection method optimised for carrier peeling.The delamination will also be raised with the raw material supplier.Smith and nephew acknowledge 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 1 HAND 6X7CM CTN 100
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8438252
• MDR Text Key: 139380787
• Report Number: 8043484-2019-00198
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4007
• Device Lot Number: 201831
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1