MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 7X9CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4006
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during wound treatment, when products were taken out of the carton, it was confirmed two edges, opening and side, of 14 pouches of a iv3000 7x9cm ctn 100 have not sealed and no dressings in them.Treatment was performed with back-up dressings.As this happened before treatment, patient was not yet involved.
Additional Manufacturer Narrative
H3, h6: the devices were returned and evaluated.Visual inspection of the returned devices found the pouches were opened at the lead-in side and one adjacent side.There was no dressing inside pouches.It confirms a relationship between the device and the reported event.The two opened sides of the returned devices were observed lacquer transfer, indicating the pouches were originally sealed.Probable cause may include the pouches were opened and dressings were taken out after distribution.The manufacturing process was reviewed.The film, primapore and release paper are laminated to form dressings and dressings are sealed in primary packaging pouch on the all-in-one machine.Empty pouch will be automatically removed by machine.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 confirmed no additional events of this nature.A review of prior escalation actions found no actions applicable to the scope of this case.The risk files mitigate the reported issue with no updates required.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 7X9CM CTN 100
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19661411
• Report Number: 8043484-2024-00066
• Device Sequence Number: 12491099
• Product Code: KGX
• UDI-Device Identifier: 05000223417369
• UDI-Public: 05000223417369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 10/01/2026
• Device Catalogue Number: 4006
• Device Lot Number: 202341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown