MAUDE Adverse Event Report: JIANGXI SANXIN MEDTEC CO.,LTD. YI XIN STERILE SYRINGE; STERILE SYRINGE FOR SINGLE USE

Model Number 15-10ML-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

The incident was evaluated by the sanxin adverse event monitoring team.Since the batch number information of the incident products was not obtained, 5 batches of the retention samples of products exported to the united states were tested, and the products met the standard requirements.The device history records(dhr) of these 5 batches were reviewed and the manufacturing process met the requirements of the approved device master record( dmr).No cause of the event product failure was found.

Event Description

A user facility's nurse reported that the syringe leaked blood out of the heparin pump during treatment.

• Brand Name: YI XIN STERILE SYRINGE
• Type of Device: STERILE SYRINGE FOR SINGLE USE
• Manufacturer (Section D): JIANGXI SANXIN MEDTEC CO.,LTD.; no.999 fushan road,; xiaolan economic development; nanchang, jiangxi 33020 0; CH 330200
• Manufacturer (Section G): JIANGXI SANXIN MEDTEC CO.,LTD.; no.999 fushan road,; xiaolan economic development; nanchang, jiangxi 33020 0; CH 330200
• Manufacturer Contact: yu jin ; no.999 fushan road,; xiaolan economic development; nanchang, jiangxi 33020-0 ; CH 330200
• MDR Report Key: 17815555
• MDR Text Key: 324217197
• Report Number: 3005246939-2023-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-10ML-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEPARIN PUMP.