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

Model Number N/A

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

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

A1-a2, a4-a6: not specified.H10: a sample of 3m micropore surgical tape was not received and no lot number was provided.3m will continue to monitor.A common practice in fluid administration is close monitoring of patients during treatment.

Event Description

Received from australia: extensive blood loss and loss of consciousness was reported after a venous fistula needle in the left forearm that was affixed with 3m micropore surgical tape dislodged.A code blue was called, and an emergency medical and nursing team stabilized the patient; fluid resuscitation was performed, digital pressure was applied to stop the further blood loss from the fistula and blood from the dialysis circuit was returned to the circulation.The patient was transferred to the emergency department for further treatment, which included fluid administration, monitoring, and hospital admission.Status is stable with no further needle dislodgements.The device used at the time was not documented in the medical records; the facility stocked both 3m micropore surgical tapes 1533-1 (tan) and 1530-1 (white) on the unit, so either could have been used (refer to emdr 2110898-2023-00105 regarding same complaint).The hospital reported that unit changes were made in response to this incident which included staff education and new securement practices with extra pieces of tape used to secure needles to the skin, sourcing of new silicone tape that is now used to secure all av fistula needles, an audible alarm for the patient placed next to the venous needles to detect blood loss if the needle is dislodged, and patient education on keeping the arm still, not touching av fistula tapes.Monitoring the needle position, and letting staff know if the needles are moving.

• Brand Name: 3M¿ MICROPORE¿ SURGICAL TAPE
• Type of Device: 3M¿ MICROPORE¿ SURGICAL TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN
• MDR Report Key: 18322999
• MDR Text Key: 330427892
• Report Number: 2110898-2021-00104
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1533-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female