MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4008

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

It was reported that, during treatment, the dressing did not adhere to the skin, so immediately was changed to another dressing.Treatment was not delayed.The patient was not harmed.

Manufacturer Narrative

Our investigation into the complaint has now concluded.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.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this issue in the past four years.No samples were received for this complaint therefore visual inspection and functional evaluation could not be performed.The device was used for treatment.During treatment, the dressing would not adhere to the skin and so another dressing was used.As with all adhesive products, the skin must be thoroughly dry before application of the dressing as this may affect the adhesive performance.Any moisture to the skin, for example caused by vigorous exercise or bathing, can also affect adhesion.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.On this occasion we have been unable to determine a definitive root cause.We have not been able to confirm a relationship between the reported event and the device.No further actions are deemed necessary at this time.However, this failure mode will be monitored for any adverse trends.Smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• 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: 9494501
• MDR Text Key: 172034536
• Report Number: 8043484-2019-00932
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: 4008
• Device Lot Number: 1812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR