MAUDE Adverse Event Report: 3M COMPANY 3M¿ TEGADERM¿ I.V. ADVANCED SECUREMENT DRESSING; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	1683
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to solventum for analysis; therefore, it is not possible to determine the root cause.A general analysis response for itching, irritation, redness, flushing, rash, blistering, or swelling can be due to skin sensitivities to adhesive products and/or attributed to improper application or removal of the product.Refer to product packaging and instructions for use for proper application and removal technique.Prepare the site according to your facility¿s protocol.Allow all preparations and protectants to dry completely before applying dressing.Application: do not stretch the dressing as tension can cause skin trauma.Removal: gently grasp an edge and slowly peel the dressing from the skin in the direction of hair growth.Avoid skin trauma by peeling the dressing back, rather than pulling it up from the skin.A review of the batch record showed this lot met all specifications for product release and no deviations were found that could have caused or contributed to the reported malfunction.Solventum will continue to monitor.
Event or Problem Description
The patient received intravenous fluid therapy via an indwelling intravenous needle, secured with a 3m¿ tegaderm¿ i.V.Advanced securement dressing.Approximately one hour after application, the patient developed skin flushing spreading from the left hand to the entire left upper limb, accompanied by scattered millet-like papules and itchy skin.The transparent dressing was immediately replaced with adhesive tape for fixation.The attending physician was notified and a 0.9% sodium chloride injection and 10mg dexamethasone sodium phosphate injection were administered intravenously.Approximately 30 minutes after medication, the patient¿s itching gradually subsided, and the rash resolved within about 2 hours.No recurrence of symptoms was observed after the adhesive tape was used for fixation.

• Brand Name: 3M¿ TEGADERM¿ I.V. ADVANCED SECUREMENT DRESSING
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 23558542
• Report Number: 2110898-2025-00067
• Device Sequence Number: 18668872
• Product Code: KMK
• UDI-Device Identifier: 00707387808150
• UDI-Public: 01007073878081501125041217280411103456F5
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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 Model Number: 1683
• Device Catalogue Number: 1683
• Device Lot Number: 3456F5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2025
• 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