MAUDE Adverse Event Report: M.C. JOHNSON TAPE AND BANDAGE, ADHESIVE

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Type  malfunction  

Event Description

During hemodialysis (hd) treatment, a patient (b)(6) reportedly lost approximately one liter of blood due to venous needle dislodgement.On (b)(6) 2017 at 8:00 am, the facility staff performed the safety check.At 8:07am, the venous needle was found dislodged from the patient and a large pool of blood was under the patient's chair.The paper tape that was used to secure the venous needle did not adhere to the patient's skin and the venous needle came out of the patient's arm.The access site was not covered.There was no indication of a malfunction or defect with the connection of the bloodlines (fresenius custom combi set) to the venous needle.The machine did not alarm as there was not a disruption of pressure on the venous side.The patient was found unresponsive at 8:07am and treatment was discontinued.The patient was given l000ml of normal saline and chest compressions (cpr) were performed.The patient became alert and stable and the clinic staff sent the patient to the er for evaluation.The patient was admitted to the hospital for two days for monitoring.The patient did not have any blood transfusions or treatment at the hospital.The patient was discharged from the hospital on (b)(6) l 7.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TAPE AND BANDAGE, ADHESIVE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): M.C. JOHNSON
• MDR Report Key: 17526656
• MDR Text Key: 321520540
• Report Number: MW5133594
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: NIPRO MEDICAL FISTULA NEEDLE.