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

Catalog Number 59410082

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/17/2020

Event Type  malfunction  

Event Description

It was reported that the dressing of the iv-3000 was creased, the surrounding protect paper fall off.So the dressing couldn't be used.

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 issues recorded in the batch log of the manufacturing records during the manufacturing process that could have caused or contributed to the issue.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device was intended for use in treatment.The returned samples were functionally evaluated which confirmed the failure mode of delamination.No creasing was observed.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.Unfortunately on this rare occasion in process checks failed to identify the failure mode and therefore the root cause was a manufacturing process issue.We were able to confirm a relationship between the event and the device.As this is a very low occurring issue, 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 6X7CM CTN 100
• 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: 10062523
• MDR Text Key: 191156526
• Report Number: 8043484-2020-00454
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111151568
• UDI-Public: 4582111151568
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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: 59410082
• Device Lot Number: 1809
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/20/2020
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1