MAUDE Adverse Event Report: 3M HEALTH CARE 3M MICROPORE SURGICAL TAPE; 3M¿ MICROPORE¿ SURGICAL TAPE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob or age, weight, ethnicity, dob or age, weight, ethnicity : no specified.A sample of 3m micropore surgical tape was not received.A retain sample from the reported lot was tested for adhesion and met all specifications.Production records were also reviewed and no issues were found.
Event or Problem Description
A venous needle that was secured with 3m micropore surgical tape dislodged with blood leakage after about 1.5 hours of dialysis treatment.The treatment started with two 15-gauge arteriovenous fistula needles.Each site had a 2x2 gauge to cushion under the needle, then was secured with four pieces of tape to stabilize the needle.

• Brand Name: 3M MICROPORE SURGICAL TAPE
• Common Device Name: 3M¿ MICROPORE¿ SURGICAL TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11674427
• Report Number: 2110898-2021-00028
• Device Sequence Number: 19707118
• Product Code: KGX
• UDI-Device Identifier: 30707387065974
• UDI-Public: 30707387065974
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 10/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 1530-1
• Device Lot Number: 33AX33
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention