MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 7X9CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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 information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during catheter fixation, the insertion of a peripheral venous cannula (pvk) resulted in a grade 2-3 decubitus ulcer on the forearm of the patient using an iv3000 ported dressing.The plastic body of the pvk lied directly on the patient's skin.This means that moisture and pressure were directly applied to the skin area.It was usual to place a fleece pad underneath, which prevented a defect in the skin.However, this fleece pad was no longer included in the pvk plaster sets with transparent plaster material and was not available separately.This meant a risk for the patient.It is unknown how this adverse event was addressed.No further complications were reported.
Event or Problem Description
It was reported that during catheter fixation, the insertion of a peripheral venous cannula (pvk) resulted in a grade 2-3 decubitus ulcer on the forearm of the patient using an iv3000 ported dressing.The plastic body of the pvk lied directly on the patient's skin.This means that moisture and pressure were directly applied to the skin area.It was usual to place a fleece pad underneath, which prevented a defect in the skin.However, this fleece pad was no longer included in the pvk plaster sets with transparent plaster material and was not available separately.This meant a risk for the patient.This adverse event was addressed by secondary wound healing with jelonet and gentle border.No further complications were reported.
Additional Manufacturer Narrative
B5, d1/d2a/d2b, d4/catalog number, udi: updated.

• Brand Name: IV3000 7X9CM CTN 100
• 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: 21532104
• Report Number: 8043484-2025-00011
• Device Sequence Number: 7134113
• Product Code: KGX
• UDI-Device Identifier: 05000223411497
• UDI-Public: 5000223411497
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4006
• Device Lot Number: 202424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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: Other
• Patient Sex: Unknown