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	Biocompatibility (2886)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Low Oxygen Saturation (2477); Blister (4537)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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 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.
Event or Problem Description
It was reported that during treatment, 12 hours in, severe itching at the site of the dressing, and there was a red patch around the puncture point, approximately 2 by 2 centimeters in size.The dressing was removed, the area was disinfected, and a new dressing was applied.Two hours later, the redness had spread to about 5 by 5 centimeters.The dressing was removed again, the area was disinfected, and a gauze dressing was applied.Subsequently, the red patch expanded to 8 by 8 centimeters, with surrounding swelling and multiple blisters ranging from 0.5 to 1 by 1 centimeters.The cvc catheter was removed and a peripheral venous catheter was inserted instead.The patient reported difficulty breathing, and the blood oxygen saturation was measured at 88%.A mask was changed to provide oxygen, and anti-asthmatic drugs were administered as per the doctor's orders.Half an hour later, the blood oxygen saturation rose to 95%, and the patient's breathing difficulty improved.The blisters were punctured with a sterile syringe, and a light yellow fluid was squeezed out.The area was disinfected with iodophor, allowed to dry, and then covered with gauze.One hour later, the patient's breathing difficulty disappeared.The area was disinfected and allowed to dry daily, and the red patch gradually disappeared.It is unknown how the treatment was completed, or if this caused any delay.

• 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: 25145006
• Report Number: 8043484-2026-00023
• Device Sequence Number: 13445069
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2026

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 Catalogue Number: 4008
• Device Lot Number: 2506
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/03/2026
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female