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

Catalog Number 59410882

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2020

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 peeled off from the frame, so it was impossible to use.A backup was available.No information about delay.The sample will be returned for investigation.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issues highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the part number provided, there have been no further complaints reported with this failure mode in the past three years.The device was intended to be used for treatment.As the returned dressing was disassembled, it was not possible to carry out a product evaluation.We have therefore not been able to confirm 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.We have not been able to 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10518221
• MDR Text Key: 206476815
• Report Number: 8043484-2020-02820
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111151575
• UDI-Public: 4582111151575
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/04/2020

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: 1923
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1