MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE PLUS 10X10CM; DRESSING, WOUND, OCCLUSIVE

Catalog Number 66800679

Device Problem Delivered as Unsterile Product (1421)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

It was reported that when a pouch was taken out of the carton, it was confirmed a part of the pouch was torn.The product was used for treatment.No patient harm.No delay was reported.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture 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.A complaint history review was carried out using the lot and part number provided, there have been no further complaints reported with these failure modes in the past three years.The device was intended for use in treatment.The photo provided by customer was observed and found a small tear in pouch, which confirms the relationship between the event and the device.As no samples were returned a product evaluation could not be carried out.A full review of manufacturing process was carried out.There are visual inspections in place during the manufacturing process to identify defective pouch as per the product specification.There are also regular tests carried out to monitor the finished product.It was possible that the paper material provided by third party supplier had a small tear and was sealed to form the pouch.The torn pouch was not picked out during the subsequent visual inspection process.The potential root cause of this failure mode could have been due to the supplied material.However due to no sample being provided, no further actions by smith and nephew are deemed necessary at this stage.We will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: HYDROSITE PLUS 10X10CM
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10763765
• MDR Text Key: 213919174
• Report Number: 8043484-2020-03364
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 04582111152343
• UDI-Public: 4582111152343
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800679
• Device Lot Number: 201947
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1