MAUDE Adverse Event Report: JIANGXI SANXIN MEDTEC CO LTD 10ML SYRINGE LUER LOCK W/OUT NEEDLE; SYRINGE, PISTON

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

A user facility¿s nurse reported that the syringe leaked blood out of the heparin pump during treatment.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 10ML SYRINGE LUER LOCK W/OUT NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): JIANGXI SANXIN MEDTEC CO LTD
• MDR Report Key: 17575248
• MDR Text Key: 321587451
• Report Number: MW5144746
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1