MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SECURA NO-STING BARRIER FILM 3MLX50SWABS; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800711

Device Problems Fluid/Blood Leak (1250); Delivered as Unsterile Product (1421)

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

Event Date 02/02/2021

Event Type  malfunction  

Event Description

It was reported that before use, it was confirmed that the contents of the secura no-sting barrier film had leaked from some pouches.An intact product in the carton was used for treatment.No delay was reported.

Manufacturer Narrative

The device intended for use in treatment, was not returned for evaluation.Therefore, we are not been able to establish a relationship between the reported event or determine a root cause.However, the retain samples were pulled and found satisfactory.A review of the manufacturing records found, that there was no evidence that the product didn¿t meet specifications at the time of manufacture.The probable root cause can be operator, fail to identify the wet pouches after the rectification of the downtime.A complaint history review found other related failures.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.

• Brand Name: SECURA NO-STING BARRIER FILM 3MLX50SWABS
• 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: 11384759
• MDR Text Key: 233746111
• Report Number: 8043484-2021-00416
• Device Sequence Number: 1
• Product Code: OMP
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800711
• Device Lot Number: 09300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1