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	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the set up for an iv fixation, it was noticed that multiple units from one (1) iv3000 1 hand 10x12cm ctn 50 had damaged seal packaging.It is unknown how the procedure was finished.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H11: internal complaint reference: case (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Additional information: h6.Correction: h6 (type of investigation and health effect - impact code): b15, f26 and f24 removed.H11: the packaging of the units were not returned for evaluation; therefore, a packaging analysis could not be performed.The review of the production records showed no manufacturing issues that could have contributed to the reported incident.A review of complaint history based on the historical data revealed similar previous events; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there have been no previous escalated actions for the part number and failure mode reported.The root cause of the reported event could not be determined without evidence.Factors that could contribute to the reported event include mishandling or damage during transport/storage that could had affected the right performance of the seal.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The products were returned for evaluation.The visual inspection performed on the returned product revealed that 5 open pouches of iv3000 were received, there is no seal transfer on the open pouch, confirming that the dressing was unsealed.The review of the production records revealed no issues were detected during the manufacturing process.A review of complaint history based on the historical data revealed similar previous events; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there have been no previous escalated actions for the part number and failure mode reported.A review of the manufacturing process has revealed that this can only occur during machine packing, due to a sealing failure.As these products are machine packed also, there is a potential that these defects can go undetected.This will only occur on small number of products before being noticed by operators, when this occurs the product are physically checked back for defects.At this time, we have reason to suspect that the products failed to meet product specifications at the time of manufacture.However, based on this investigation, the need for corrective action is not indicated.

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22155547
• Report Number: 8043484-2025-00060
• Device Sequence Number: 18313685
• Product Code: KGX
• UDI-Device Identifier: 05000223040086
• UDI-Public: 5000223040086
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2025

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: 05/01/2025
• Device Catalogue Number: 4008
• Device Lot Number: 2420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 11/28/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/03/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2024
• 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