MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE AD PLUS 7.5 X 7.5CM; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800674

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that when the pouches were opened, it was confirmed a tiny black foreign substance has adhered on the wound-contact side of three hydrosite ad plus 7.5 x 7.5cm.The treatment was completed, without delay, using a s+n back up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the device, was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Cutting the foam pad and observing it under the microscope revealed the foreign bodies in the pad, suspected to be a hypol solidified substance.The root cause has been determined as a manufacturing process issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.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.Operators were made aware of this complaint and re-trained the in-process inspection work instruction.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Additional information: d4, h4.

Manufacturer Narrative

H3, h6: the device, was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Cutting the foam pad and observing it under the microscope revealed the foreign bodies in the pad, suspected to be a hypol solidified substance.The root cause has been determined as a manufacturing process issue.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.A complaint history review revealed a small number of similar events for this nature with manufacturing problems observed.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.No historical escalation have been observe and there are no open corrective actions operators were made aware of this complaint and re-trained the in-process inspection work instruction.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: HYDROSITE AD PLUS 7.5 X 7.5CM
• 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: 13478443
• MDR Text Key: 285958542
• Report Number: 8043484-2022-00050
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223468989
• UDI-Public: 5000223468989
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

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 Catalogue Number: 66800674
• Device Lot Number: 202127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 03/07/2022; 10/10/2022
• Supplement Dates FDA Received: 03/08/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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