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

Model Number 59410082

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

It was reported that, before use, it was confirmed there was a resin lump-like foreign substance under the fixing tape of the iv3000 window frame 6x7cm ctn 100.As this was notice during set up or inspection, not patient was involved.

Manufacturer Narrative

H3, h6: 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 the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review found no similar instances of the reported event in the last 3 years.The device intended for use in treatment was returned.On inspection there was an unidentified substance which was located between the fixing strip and its adhesive layer.This confirmed a relationship between the reported event and the device.These strips are not manufactured by smith and nephew and are added to the dressing at the end of the process.Probable root cause is therefore a missed quality check during the final process of manufacture.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: 12389162
• MDR Text Key: 268934145
• Report Number: 8043484-2021-01703
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00040565120584
• UDI-Public: 00040565120584
• 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: 10/22/2021

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 Model Number: 59410082
• Device Catalogue Number: 59410082
• Device Lot Number: 2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/22/2021
• Patient Sequence Number: 1