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

Catalog Number 59410882

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

It was reported that when the customer removed the carrier#2, the film dressing adhered to the carrier#2 and got peeled off from the frame.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the dressing was never used by the patient, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

We have now completed our investigation into this complaint.The returned samples have been assessed and the reported issue can be confirmed.In april 2017 the manufacturing line where iv3000 window frame is produced was part of a continuous improvement project.This project included some modifications to the manufacturing line to improve the consistency and presentation of both the adhesive film and the window frame carrier paper.At the same time improvements were also made to the production line that produces the raw material used to manufacture the final product.This work included an upgrade of the sensors used to control the tension within the bulk rolls.As well as this a reduction in the overall length of the rolls was implemented as this also helped to reduce the faults occurring in the final product a combination of the upgrade and modification to the manufacturing lines has shown measurable improvements in the consistency and quality of the product.Smith and nephew are continually investigating ways to develop and improve our products and 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: 8204252
• MDR Text Key: 131706832
• Report Number: 8043484-2018-00465
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2019

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: 59410882
• Device Lot Number: 1732
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/11/2018; 12/11/2018
• Supplement Dates FDA Received: 02/13/2019; 06/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1