MAUDE Adverse Event Report: JMS NORTH AMERICA CORP. / JMS SINGAPORE PTE. LTD JMS FISTULA WINGEATER 15G X 1BE/CL; NEEDLE, FISTULA

Model Number 820-5002-33

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Event Description

An rn (registered nurse), clinical coordinator reported to customer service that 820-5002-33 jms fistula wingeater 15g x 1be/cl from jms north america corp: needles dull making it harder to cannulate access.Unsafe, hard to retract needle from patient's arm.More access bleeding using this needle, more complaints of pain.The safety feature does no engage easily.Needle too short, difficulty with deeper access.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: JMS FISTULA WINGEATER 15G X 1BE/CL
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS NORTH AMERICA CORP. / JMS SINGAPORE PTE. LTD
• MDR Report Key: 19005399
• MDR Text Key: 339048936
• Report Number: MW5153375
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 820-5002-33
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Patient Sequence Number: 1