MAUDE Adverse Event Report: JMS WINGEATER; NEEDLE, FISTULA

Catalog Number 820-5002-33

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

During hemodialysis (hd) treatment, a patient (b)(6) reportedly lost approximately 800 to 1000 milliliters (ml) of blood after the venous needle became disconnected from the bloodlines.The event occurred approximately two hours and forty-five minutes into the hd treatment.The patient was able to complete treatment on the same hd machine.No patient adverse reaction was reported.The patient went to the emergency room (er) for a precautionary check of the patient's hemoglobin.The results were within normal range and the patient was sent home and was not admitted to the hospital.There was no indication of a needle and/or bloodline malfunction or defect.No samples are available to be returned.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WINGEATER
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS
• MDR Report Key: 17526815
• MDR Text Key: 321052331
• Report Number: MW5133752
• 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: 09/05/2017

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
• Device Catalogue Number: 820-5002-33
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1