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	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
It was reported that, the outer packaging of one (1) iv3000 1 hand 10x12cm ctn 50 was found to be unsealed by the nurse.As this was noticed upon inspection, there was not patient involvement.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.An evaluation of the device through a visual inspection of the material provided by the customer, was performed and revealed that the outer packaging of one iv3000 hand 10x12cm was unsealed.A review of the associated batch record showed that this batch passed all acceptance criteria and was compliant upon release for distribution.An analysis of the complaint history revealed a small number of similar instances in the last 12 months, with only this one is reported with this lot number.An assessment to identify prior capa/nc/pra/hhe/field actions was executed and determined no escalations relating to the reported event.A review of the risk management documentation was performed and concluded that the alleged failure and associated foreseeable harms have been anticipated under multiple failure modes.The probable cause remains unknown.A factor that could contribute to the reported event include that the dressing has not been stored in the conditions outlined in the ifu.As temperature can alter the adhesive nature of the seal of the pouch, the device should be stored in the optimum conditions as indicated in the ifu.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: 17684716
• Report Number: 8043484-2023-00057
• Device Sequence Number: 2582793
• 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): 08/12/2024

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: 2230
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 08/12/2024
• 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