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

Catalog Number 4007

Device Problem Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

It was reported that when the iv3000 pouch was opened, it was confirmed the film had been creased, so it was not used for treatment.This happened with three dressings.A backup was available.No delay was reported.The samples will be returned for investigation.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing record 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 and lot provided, there have been further complaints reported with this failure mode in the past three years.It was reported that the dressings were used for treatment and creasing was found on the film.The returned samples were visually and functionally evaluated which confirmed this issue.There are checks in place to prevent creasing of the film.If creasing is identified during in-process checks, it is tabbed and recorded in the fault log.On this occasion the operator appears to have missed the issue.Minor creasing can sometimes occur in the film during the adhesive application process at the start or end of the roll.Again visual checks are in place to identify this.The root cause was a raw material issue and a relationship was confirmed between the device and event.As the occurrence of this failure mode is within acceptable range, 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 1 HAND 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: 10852774
• MDR Text Key: 216643354
• Report Number: 8043484-2020-03878
• 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: 201945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1