MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SMALL NPWT FOAM FILLER KIT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801088

Device Problems Gas/Air Leak (2946); Infusion or Flow Problem (2964)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during npwt utilizing a renasys foam filler kit, air leakage occurred.It was confirmed that there was a damage on the softport.Applying the fixation strip did stop the leak.But, the soft port was replaced and treatment was continued.There was no patient harm.No delay was reported.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root cause is a damaged component.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.Additional information: d4, h4.

• Brand Name: SMALL NPWT FOAM FILLER KIT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11536873
• MDR Text Key: 241357308
• Report Number: 8043484-2021-00659
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111152978
• UDI-Public: 4582111152978
• Combination Product (y/n): N
• PMA/PMN Number: K110647
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 66801088
• Device Lot Number: 2019120299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1