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  

Event Description

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

Manufacturer Narrative

The incident was evaluated by the sanxin adverse event monitoring team.The retention sample of the incident product (lot no.20220815) was tested and the product met the standard requirements.The device history record(dhr) for this batch was reviewed and the manufacturing process met the requirements of the approved device master record(dmr).No cause of the event product failure was found.

• 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: 17815548
• MDR Text Key: 324223731
• Report Number: 3005246939-2023-00001
• 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
• Device Lot Number: 20220815
• 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
• Date Device Manufactured: 08/15/2022
• 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