MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD CAINA; ANTISTICK NEEDLE

Model Number 25501

Device Problem No Fail-Safe Mechanism (2990)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The current production process also investigated and reviewed, and no information showed that the current production process may produces the needles popped off syringes.A device history record review was completed for the lot numbers, no defects or imperfections were observed.

Event Description

Customer reports:when he was injecting the influenza the needle popped off the syringe while the needle was still inserted in the patient's thigh.Some of the medication squirted out when syringe detached from the needle causing only 1/2 the dose to be administered.

• Brand Name: CAINA
• Type of Device: ANTISTICK NEEDLE
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD; no.23 huanxi rd. zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer (Section G): JIANGSU CAINA MEDICAL CO., LTD; no.23 huanxi rd. zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: jianwei pan ; no.23 huanxi rd. zhutang town; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 16076470
• MDR Text Key: 308463373
• Report Number: 3005670221-2022-00005
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193526
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25501
• Device Catalogue Number: CA255
• Device Lot Number: 89721010001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1