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

Catalog Number 59410082

Device Problems Loss of or Failure to Bond (1068); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Event Description

It was reported that the customer is dissatisfied with the adhesive property.Product does not adhere as strongly as the 3m product before the switch to iv3000.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes could include application techniques or a defective product.A review of the associated batch manufacturing records could not be carried out as no batch/lot number was provided.The complaint history review found further instances of the reported event in the past years.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

Event Description

It was reported that during the care of peripheral venous catheters, the customer reported the product did not stick.A backup was available.No patient harm reported.

• 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10623804
• MDR Text Key: 209698737
• Report Number: 8043484-2020-03118
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 59410082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1