MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD; RETRACTABLE SAFETY SYRINGE

Model Number 3ML 25G X 1"

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported by the customer that it was difficult to get all the air bubbles out without wasting medication and that after the medication is drawn up, it spills out after the spring is activated and the needle vanishes.No information was received regarding any serious injury as a result of this report.

Manufacturer Narrative

No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.

• Type of Device: RETRACTABLE SAFETY SYRINGE
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD; no.23 huanxi road, zhutang; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: camel zhou ; no.23 huanxi road, zhutang; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 18523331
• MDR Text Key: 333157971
• Report Number: 3005670221-2022-00010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3ML 25G X 1"
• Device Catalogue Number: 16-SNR3C251S
• Device Lot Number: CJCJ12-01
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 01/17/2024
• Patient Sequence Number: 1