MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN IV3000 1-HAND; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05003902

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

It was reported that the paper backing on the back of the dressing did not peel correctly and the dressing could not be used.No case involved.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains no further instances/ related events of the reported event.The device was intended for use in treatment.As no samples were returned a product evaluation could not be carried out.Potential causes for the reported issue may be; - delamination - adhesion levels - application technique 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.

• Brand Name: UNKN IV3000 1-HAND
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10819717
• MDR Text Key: 215864547
• Report Number: 8043484-2020-03812
• Device Sequence Number: 1
• Product Code: KGX
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

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 Catalogue Number: UNKN05003902
• Device Lot Number: 2010
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1