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

Catalog Number	4008
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that during set up for a picc treatment one (1) iv3000 1 hand 10x12cm ctn 50 was found that the packing bag was damaged and the dressing was not sticky.The treatment was performed, without any delay, using a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the product, could not be returned for evaluation; therefore, a device analysis could not be performed.The attached supplied image confirms only one of the reported issues, showing pouch paper torn however we cannot report on the dressing adhesion as this is not shown in the supplied image.A review of the production record showed that this batch passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A review revealed no escalations actions relating to the reported event.A review of the complaint history revealed 38 similar events for the listed product for the timeframe.For the batch number, the review did not reveal any similar events.According to the opsite iv3000 product range specification, the dressing passes through an in-process critical test parameters including product appearance and adhesion testing.A review of the risk management file revealed this failure mode/adverse event was previously identified.The anticipated risk level is still adequate.A historical review identified 2 complaints relating to pouch seal failures, 2 complaints relating to damaged packaging and 229 complaints relating to lack of adhesion, therefore, with a probability rating of ¿a ¿ improbable¿ this is considered as acceptable (no impact to the risk file ratings).With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include insufficient preparation of the patient's skin prior to the application of the dressing, an incorrect application of the dressing or storage temperature fluctuations.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18607775
• Report Number: 8043484-2024-00011
• Device Sequence Number: 16825044
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/06/2024

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: 08/31/2025
• Device Catalogue Number: 4008
• Device Lot Number: 2235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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