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

Catalog Number 4007

Device Problem Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

It was reported that when the release papers were removed, the film was lifted and removed with them, so it could not be used for treatment.Plural dressings in the carton were affected.A backup was available.No delay was reported.

Manufacturer Narrative

H6: we have now concluded our investigation into this complaint.The batch record was 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 further complaints reported with this failure mode in the past three years.The device was intended to be used for treatment.The returned sample was visually and functionally evaluated, and could not be confirmed the failure mode.According to the description of complaint, the complaint issue is carrier delamination.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 were able to confirm a relationship between the event and the device.The root cause was determined as a manufacturing process issue.As the occurrence rate is within acceptable range, no further actions by smith and nephew are deemed necessary at this stage.This complaint information will be shared with the relevant manufacturing team.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 1 HAND 6X7CM CTN 100
• 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: 10858053
• MDR Text Key: 216824282
• Report Number: 8043484-2020-03902
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• 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: 01/05/2021

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: 4007
• Device Lot Number: 202009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1