MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SECURA NO-STING BARRIER FILM 3MLX50SWABS; TAPE AND BANDAGE, ADHESIVE

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 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when a pouch was taken out from the carton, it was confirmed there was a leakage, so it could not be used.A backup was available.No delay was reported.

Manufacturer Narrative

The device intended to be used in treatment was not returned for evaluation, all provided information and images have been reviewed and we have been able to establish a relationship between the device and the reported event.Probable root cause may include, contact with another source or manufacturing process issue.A review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture, a complaint history review found further instances of the reported event.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: 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: 11118162
• MDR Text Key: 225119088
• Report Number: 8043484-2021-00022
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 66800711
• Device Lot Number: 09300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2020
• 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