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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was not provided.A sample of transpore surgical tape was received from the customer.The sample was tested for adhesion and met all specifications.Production records were also reviewed and product met adhesion specifications.Two types of tape were used to secure the patient's venous dialysis needle in this report.Although the nurse reported she thought the venous dialysis needle became dislodged when the patient pulled up his blanket, 3m is sending mdr reports for both of the tapes used to secure the venous dialysis needle in this reported event.2110898-2019-00026 was sent for 1532-1 micropore plus paper tape.2110898-2019-00027 was sent for 1527-1 transpore surgical tape.End of report.
Event or Problem Description
A nurse from an outpatient dialysis clinic reported a patient experienced a venous dialysis needle dislodgement.The venous needle was allegedly secured to the patient with 3m¿ micropore¿ plus paper tape and 3m¿ transpore¿ surgical tape.The nurse reported the patient fell asleep during dialysis.When the patient pulled up his blanket, the venous needle got caught, and was pulled out.The patient alerted the staff who responded immediately.The dialysis machine was turned off.The estimated blood loss was 500cc.Approximately one-half pint of blood was returned through the arterial dialysis needle.An unspecified amount of saline was also administered through the arterial dialysis needle.The patient was alert and orientated during the entire event.Dialysis was discontinued, the patient was monitored, and was eventually discharged home.The patient returned to the dialysis clinic for his regularly scheduled routine dialysis treatments.

• Brand Name: 3M TANSPORE SURGICAL TAPE
• Common Device Name: TRANSPORE¿ TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8347925
• Report Number: 2110898-2019-00027
• Device Sequence Number: 2035529
• Product Code: KGX
• UDI-Device Identifier: 30707387065950
• UDI-Public: 30707387065950
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/18/2019

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 1527-1
• Device Lot Number: 2021-12 AI
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/18/2019
• 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: Other
• Patient Age: 78 YR