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

Model Number 59410082

Device Problem Peeled/Delaminated (1454)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that it was impossible to remove the window frame part of the product.When the frame was removed in the last action to apply the dressing, the film peeled off from the skin.No patient harm.A backup was available.No information about delay.The sample will not be returned because of contamination, and no photo is available.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 into this complaint.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 issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.The complaint history file contains no further instances/ related events of the reported event.The device was intended to be used for treatment, however, issues were experienced during application.As no samples were returned a product evaluation could not be carried out.The reported issue may have been caused by delamination.Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process.During the manufacturing of the dressing, in process checks are undertaken for this product.All material is manufactured according to the specification and only product meeting the release criteria will be passed on for further processing.Other causes may include user variance during application.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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: 10941819
• MDR Text Key: 219478165
• Report Number: 8043484-2020-04049
• 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: 12/18/2020

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: 1944
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1