MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 7X9CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4006
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, before use, it was confirmed the non-woven part of the dressing was creased and the adhesive on that part was weak.The procedure was completed without delay using a smith & nephew back-up device.No other complications were reported.
Additional Manufacturer Narrative
We have now completed our investigation into the reported complaint.The device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual inspection confirmed the non-woven part of the dressing was creased and the adhesive on that part was weak.A non-woven raw material quality issue has been identified as the root cause.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 7X9CM CTN 100
• Common Device Name: 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: 11671053
• Report Number: 8043484-2021-00840
• Device Sequence Number: 17018955
• Product Code: KGX
• UDI-Device Identifier: 05000223417369
• UDI-Public: 05000223417369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4006
• Device Lot Number: 201945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1