MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4007

Device Problems Unsealed Device Packaging (1444); Problem with Sterilization (1596)

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

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that primary product package is delivered opened, therefore product not sterile anymore.Product film and adhesive seems to be misplaced.No harm or injury reported.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.The device, intended to be used in treatment, has been returned for evaluation.The assessment confirmed that the device pouch was opened and the film was misplaced, establishing a relationship with the reported event.A failed segregation of the product used for inspection has been identified as the root cause.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found one further instance of the reported event in the past three years.There are actions being taken to reduce further instances including physical segregation of the inspected product.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.

• Brand Name: IV3000 1 HAND 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: 10971617
• MDR Text Key: 220411852
• Report Number: 8043484-2020-04125
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: 4007
• Device Lot Number: 201939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1