MAUDE Adverse Event Report: 3M COMPANY 3M¿ MULTIPORE¿ DRY SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number	3730-0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Unintended Extubation (4564)
Date of Event	03/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged event is related to the 3m¿ multipore¿ dry surgical tape.Samples are pending return to solventum for analysis.
Event or Problem Description
A hospital reported that an unplanned extubation occurred with an infant while in the nicu resulting in bradycardia and desaturation.The endotracheal tube slipped through the 3m¿ multipore¿ dry surgical tape, which was used to secure the endotracheal tube to a neobar endotracheal tube holder.The tape was wrapped around the post on the neobar once, then wrapped around the neobar post and the endotracheal tube 2-3 times.The tape was in place for 10 hours and was changed two times over seven days prior to the incident.A bag and mask for positive pressure ventilation was required to recover from the bradycardia and desaturation.Reintubation was required.
Additional Manufacturer Narrative
Retained samples were tested from this lot and no issues were found.A review of the manufacturing 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.

• Brand Name: 3M¿ MULTIPORE¿ DRY SURGICAL TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M YAMAGATA; 5500 oaza-osanagi; yamagata; higashine-shi
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 22500631
• Report Number: 2110898-2025-00036
• Device Sequence Number: 9403046
• Product Code: KGX
• UDI-Device Identifier: 34550309236879
• UDI-Public: 01345503092368791726042310202405MA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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 Expiration Date: 04/23/2026
• Device Model Number: 3730-0
• Device Catalogue Number: 3730-0
• Device Lot Number: 2024-05-MA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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 Age: 20 DA
• Patient Sex: Male
• Patient Weight: 1 KG