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

Catalog Number 59410882

Device Problems Difficult to Remove (1528); Premature Separation (4045)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that the window frame cannot detach easily and the film easy to peel off after applied.No harm nor injury reported.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number only.There have been 8 further complaints reported with this issue in the past 4 years.As no samples were returned a thorough product evaluation could not be carried out.It was reported that the product was used in treatment and the film was easily peeled off after application.No patient harm was reported.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.It was also reported that the frame cannot detach easily during application.This could potentially be related to the product material.Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process.We have not been able to confirm the failure mode or identify a definitive root cause on this occasion.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• 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: 9475756
• MDR Text Key: 176872530
• Report Number: 8043484-2019-00913
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1