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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Infiltration into Tissue (1931); Stenosis (2263)

Event Date 09/02/2016

Event Type  Injury  

Event Description

A hemo dialysis patient (initials (b)(6), female) experienced a venous access infiltration twice during a regularly scheduled 4-hour hemodialysis (hd) treatment on (b)(6) 2016.After the second time, the treatment was terminated and the patient's arm was elevated and ice was put on the arm.The patient was sent home and no other intervention was necessary.Six days after the incident, the patient's surgeon evaluated the access site due to a history of problems regarding the patient's access site, and the surgeon found central vein stenosis and performed an angioplasty.The patient has since returned to the clinic for continued hd therapy without any further issues.The clinic manager reported that the patient has an upper right arm fistula and moves a lot and infiltrated the needle during treatment.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: 17531010
• MDR Text Key: 321136975
• Report Number: MW5137926
• 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: 09/28/2016

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