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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Blood Loss (2597)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: full list of medical products: fresenius 2008 t hemodialysis machine; combiset hemodialysis tubing; 180 nre optiflux dialyzer; granuflo 2.0k, 2.5 ca, 1.0 mg, 100 dextrose; naturalyte 4000 rx12 bicarbonate (45x); fresenius 1000 ml normal saline; jms wingeater safety av fistula needle set 15 gauge x1 inch be with clamp.Mw (b)(4) received from fresenius.End of report.
Event or Problem Description
Patient arrived for treatment alert and orientated.Pre-dialysis vital signs obtained: b/p: 187/62; pulse 72; resp 18; temp: 98.0.At 19:59, the patient was observed with the access uncovered and no bleeding from site.At 20:01, approximately 2.5 hours into the scheduled 4 hour hemodialysis treatment, during the q 30 minute vital signs check, the patient was noted to be slow to respond.Vs obtained: b/p 47/26; pulse 64.Patient's venous needle was dislodged with tape intact on the wings of the needle.Large amounts of blood were noted on both the chair and the floor.Elb 500 ml.The venous line was clamped, and pressure applied to the venous cannulation site.Normal saline was administered via the arterial needle.911 was called.After infusion of approximately 1000 ml normal saline, b/p: 126/53; pulse 64; patient was alert and oriented.Upon discharge from the facility via ems; the patient was alert and oriented with b/p 110/50; pulse 67; resp 18.The patient was transported to the hospital and admitted.The patient returned to the facility for hemodialysis on (b)(6) 2018.

• Brand Name: 3M MICROPORE PAPER TAPE PLUS
• Common Device Name: MICROPORE¿ PLUS PAPER TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8257683
• Report Number: 2110898-2019-00012
• Device Sequence Number: 2035793
• Product Code: KGX
• UDI-Device Identifier: 04046719352586
• UDI-Public: 04046719352586
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: 10/06/2021
• Device Model Number: N/A
• Device Catalogue Number: 1532S-1
• Device Lot Number: 333GKY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/17/2019
• 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: Hospitalization
• Patient Age: 69 YR
• Patient Weight: 88