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

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

We have now concluded our investigation for the complaint received.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 failure mode in the past three years.The device is intended for use in treatment.It was reported that the dressings had low adhesion, a creased film and that the carrier was raised.Images provided showed the issue of delamination.The returned dressings were evaluated.A visual inspection did not identify a creased film on any of the dressings.During a functional evaluation low adhesion was not found on any of the dressings.However delamination was identified on three of five returned dressings.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.We have not been able to confirm a relationship between the reported low adhesion and creasing and the device.We were, however, able to confirm a relationship between the reported raised carrier and the device.The root cause was determined as a manufacturing defect.As this is a very low occurring issue, no further actions are deemed necessary.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.

Event Description

It was reported that during investigation was found that three dressing presented delamination problems.No patient involved.

• Brand Name: IV3000 WINDOW FRAME 6X7CM CTN 100
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hussle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10129434
• MDR Text Key: 194357574
• Report Number: 8043484-2020-00670
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1