MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number	66024008
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During set-up/inspection of treatment, when a iv3000 1 hand 10x12cm pouch was opened, it was confirmed there was a dust-like foreign substance in it.Treatment was completed, without any delay, with a backup.No injury or other complications were reported.
Additional Manufacturer Narrative
The device was not returned for analysis.No photographs were provided in support of this complaint.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported during set-up/inspection of treatment, when a iv3000 1 hand 10x12cm pouch was opened, it was confirmed there was a dust-like foreign substance in it.Probable cause is that the dust is too small and too light in color, the equipment cannot be detected and rejected.The batch records were 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 complaint history review revealed a similar instances in the last three years.A review of prior escalation actions found no actions applicable to the scope of this case.A risk management review concluded that without further information the alleged failure mode can not be directly linked to a specific failure mode within the risk file although it does contain several failure modes that can result in contamination, of which have a worst case risk rating of medium risk level and is still adequate.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: IV3000 1 HAND 10X12CM CTN 50
• Common Device Name: 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: 14292285
• Report Number: 8043484-2022-00152
• Device Sequence Number: 1596004
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: 202105
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 08/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown