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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Information was not provided.A sample of micropore plus paper tape was received from the customer.The sample was tested for adhesion and met all specifications.Production records were also reviewed and no issues were found.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 that were 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 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 MICROPORE PAPER TAPE PLUS
• Type of Device: MICROPORE¿ PLUS PAPER TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH, WERK; manufacturing medical devices; edisonstrasse 6; kamen, 59174 ; GM 59174
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8347904
• MDR Text Key: 136499428
• Report Number: 2110898-2019-00026
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04046719352586
• UDI-Public: 04046719352586
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 1532-1
• Device Lot Number: 2021-02 OA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR