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

Catalog Number	4006
Medical Device Problem Codes	Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, the release plastic (3) of the iv3000 becomes loose and this causes the plastic to wrinkle so the dressing cannot be used.The procedure was completed with a back-up dressing with a short delay.No patient harm reported.
Additional 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, there have been further complaints reported with this failure mode in the past three years.The device, intended for use in treatment, has not been returned for evaluation.No additional information was provided.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.It was reported that during set up the creasing was found on the film.Potential factors that can contribute to the reported event include a raw material issue.This investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: IV3000 7X9CM CTN 100
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10752202
• Report Number: 8043484-2020-03314
• Device Sequence Number: 13718469
• Product Code: KGX
• UDI-Device Identifier: 05000223417369
• UDI-Public: 05000223417369
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 202013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1