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

Model Number	59410082
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: 12389162
• Report Number: 8043484-2021-01703
• Device Sequence Number: 11656831
• Product Code: KGX
• UDI-Device Identifier: 00040565120584
• UDI-Public: 00040565120584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1