MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. LARGE NPWT FOAM FILLER KIT; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801090

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during the set up for npwt, when a large npwt foam filler kit was opened, the pouch was not crimped and was not kept sterilized.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device was returned for evaluation, confirming the reported event, the root cause remains unknown.A visual inspection confirmed that the seal was not intact.Although the seal was confirmed to be incomplete, there is clear evidence of adhesive transfer in the seal area, which confirms that this product was fully sealed during the manufacturing process.The probable root cause may include the seal may have been inadvertently opened when taken out of the packaging case, or that it failed during the transportation and storage stage.A documentation review has been conducted, confirming that no manufacturing problems or sterility issues have been observed.No previous complaints of this nature are recorded, historical observations detail that this issue is fully captured within the preliminary risk assessment.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed no corrective actions deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: LARGE NPWT FOAM FILLER KIT
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12782720
• MDR Text Key: 280806411
• Report Number: 8043484-2021-01946
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111152992
• UDI-Public: 4582111152992
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 66801090
• Device Lot Number: 2020090917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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