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

Model Number	66024008
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Erosion (2075); Blister (4537)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during wound treatment, patient was dying and maintained by multiple drugs.A deep vein puncture was carried out and the iv3000 1 hand 10x12cm ctn 50 was applied.The next day, the nurse found that rice like blisters of different sizes around the puncture site and a 2cmx1cm size skin was broken, and red shallow tissue could be seen.The affected area was disinfected with iodophor, replaced with alginate dressing, and gave allergic medication.The wound did not deteriorate.However, despite treatment gave to the patient, died two days later.
Additional Manufacturer Narrative
H3, h6: it was reported that during wound treatment, patient was dying and maintained by multiple drugs.A deep vein puncture was carried out and the iv3000 1 hand 10x12cm ctn 50 was applied.The next day, the nurse found that rice like blisters of different sizes around the puncture site and a 2cmx1cm size skin was broken, and red shallow tissue could be seen.The affected area was disinfected with iodophor, replaced with alginate dressing, and gave allergic medication.The wound did not deteriorate.However, despite treatment gave to the patient, died two days later.The device was not returned for analysis.We have therefore not been able to confirm a relationship between the event and the device, or identify a definitive root cause.The batch records were reviewed.It was confirmed that the product(s) had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review review revealed a small number of similar instances to the reported event in the last 12 months.There is nothing to suggest that this is outside of acceptable rates of occurrence.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.A clinical review concluded that it was unlikely that the patient's death was related to the use of the iv3000 dressing, that the cause of death was reported as being multiple organ failure.Furthermore, it was reported that after the affected site was treated, no further deterioration to the skin was noted.There were no clinical factors found (relating to the use of the iv3000 dressing) which would have definitively contributed to the event.The instructions for use for this product has been reviewed.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressing, and skin preparation prior to use.A review concluded that there are no prior escalated actions related to this part number and failure mode.The probable root cause for this complaint is patient skin sensitivity to one or more of the components of the dressing and/or an existing skin condition.It might also be the case that the patient's skin was not prepared adequately before the dressing was administered, or that the wrong type of dressing was used for the wound level.This investigation is now complete with no corrective actions required.We will continue to monitor for any adverse trends relating to this product range.Smith & nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• 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: 16134382
• Report Number: 8043484-2023-00006
• Device Sequence Number: 3326915
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: 2118
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown