MAUDE Adverse Event Report: JMS NORTH AMERICA CORPORATION JMS, AV FISTULA NEEDLE SET 15 GA. X 1" TWIN PACK; NEEDLE, FISTULA

Lot Number 220505381

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

It was reported to fresenius medical care that a patient reported arterial clamp was engaged with tubing straight under clamp but blood continued to come out of tubing.Venous needle line clamp functioned without problem.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: JMS, AV FISTULA NEEDLE SET 15 GA. X 1" TWIN PACK
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS NORTH AMERICA CORPORATION; 22320 foothill blvd.; suite 350; hayward CA 94541
• MDR Report Key: 19098427
• MDR Text Key: 340198011
• Report Number: MW5153816
• 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: 04/10/2024

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 Lot Number: 220505381
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Patient Sequence Number: 1