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

Catalog Number	4008
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
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 treatment, it was noticed that the outer packaging of one (1) dressing from a iv3000 1 hand 10x12cm ctn 50 was leaking.The treatment was completed without any delay using a s+n back-up dressing.Since this was noticed before treatment, 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.Device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.No similar events were found in the complaint history; therefore, this would suggest it is an isolated event.A review of the risk management file revealed this failure mode/adverse event was previously identified.The anticipated risk level is still adequate.With the results of this investigation the root cause of this event could not be determined.There is insufficient information to determine how iv3000 could leak.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: 19296565
• Report Number: 8043484-2024-00053
• Device Sequence Number: 14916688
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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
• Device Catalogue Number: 4008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown