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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD CAINA; ANTISTICK NEEDLE
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JIANGSU CAINA MEDICAL CO., LTD CAINA; ANTISTICK NEEDLE Back to Search Results
Model Number 25501
Device Problem No Fail-Safe Mechanism (2990)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/26/2022
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
Despite the needle being tighten on the syringe, after administration the needle popped off the syringe fell on exam table next to the patient.
 
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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
MDR Report Key16076445
MDR Text Key308533986
Report Number3005670221-2022-00004
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193526
Number of Events Reported1
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 12/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25501
Device Catalogue NumberCA255
Device Lot Number89721010001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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