MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 26X11CM JP CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800146

Device Problem Contamination (1120)

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

Event Date 04/15/2022

Event Type  malfunction  

Event Description

It was reported that, before use, it was confirmed there was a foreign substance in the product.A backup was available.No injury or other complications were reported.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device, intended to be used in treatment, has been returned and evaluated.Visual inspection did not find a foreign substance.The assessment cannot establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes may include something sticking to the film raw material.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A review of complaint history did not reveal similar events for the listed batch and part number with no manufacturing problems observed.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A review concluded that there are no prior escalated actions related to this part number and failure mode.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST-OP VISIBLE 26X11CM JP CTN 20
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14290316
• MDR Text Key: 290950118
• Report Number: 8043484-2022-00143
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223463281
• UDI-Public: 5000223463281
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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: 02/01/2024
• Device Catalogue Number: 66800146
• Device Lot Number: 202108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1