MAUDE Adverse Event Report: JMS NEEDLE, FISTULA

Catalog Number 820-5002-33

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

During hemodialysis treatment, a patient was reported to have lost approximately 100ml of blood after a venous needle dislodged from the cannulation site.The patient was sleeping at the time of the incident.Upon discovery of the disconnection, the needle was replaced and treatment was resumed.There was no report of patient injury as a result of the issue.The patient was able to complete the treatment without further complication.The patient's post treatment condition was reported to be stable.C-126567(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEEDLE, FISTULA
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS
• MDR Report Key: 17536444
• MDR Text Key: 321136911
• Report Number: MW5143332
• 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: 03/01/2018

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