MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; SOLUTION, DECALCIFIER, ACID CONTAINING

Catalog Number 4008

Device Problem Nonstandard Device (1420)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Case (b)(4).

Event Description

It was reported that when the nurse tried to change the iv3000 dressing of the picc for the patient, it was found that the film was separated from the protection paper, so it was then replaced with another dressing.It is unknown if there was a delay.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issues documented in the batch manufacturing records 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.The complaint history file contains no further instances/ related events of the reported event.It was reported that the product intended to be used for treatment was found to have no adhesive on the release paper.The returned samples were evaluated which confirmed a relationship between the event and the device.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.The root cause was traced to the manufacturing process.As the occurrence of missing adhesive is within acceptable range, no further actions are deemed necessary at this stage.However, the details of this complaint will be shared with the relevant manufacturing team.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.(b)(4).

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• Type of Device: SOLUTION, DECALCIFIER, ACID CONTAINING
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11327110
• MDR Text Key: 233267601
• Report Number: 8043484-2021-00328
• Device Sequence Number: 1
• Product Code: KDX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• 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: 03/17/2021

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: No Information
• Device Catalogue Number: 4008
• Device Lot Number: 1925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/17/2021
• Patient Sequence Number: 1