MAUDE Adverse Event Report: JMS NORTH AMERICA CORPORATION JMS WINGEATER; NEEDLE, FISTULA

Device Problems No Audible Alarm (1019); Device Dislodged or Dislocated (2923)

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

Event Date 07/28/2016

Event Type  Injury  

Event Description

A hemo dialysis patient (initials (b)(6) female) was found unresponsive on (b)(6) 2016 at 11:53.Upon arrival to patient, blood was found on the floor and venous needle dislodgement was noted.The patient moves arm a lot and is suspected to have accidentally dislodged the needle, which is taped down onto the arm.The normal venous limits were properly set.However, the machine did not alarm to notify the staff.600ml of normal saline bolus was administered to the patient.The patient became alert and oriented; vital signs were stable; blood pressure 160/86; heart rate 118 and regular.Emergency medical system 911 was notified and the patient was sent to the hospital via ambulance.The staff caring for the patient estimated 250cc of blood loss.The patient did not require a blood transfusion at the hospital.Pre hgb 9.9 on (b)(6) 2016, hgb 9.3 at the hospital.The patient was discharged from the emergency room in stable condition.The venous needle brand is jms 15g.Catalog and lot number are unknown.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: JMS WINGEATER
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS NORTH AMERICA CORPORATION
• MDR Report Key: 17533477
• MDR Text Key: 321053084
• Report Number: MW5140381
• Device Sequence Number: 1
• Product Code: FIE
• 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: 08/24/2016

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