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U.S. Department of Health and Human Services

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

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JIANGSU CAINA MEDICAL CO., LTD; SYRINGE, PISTON Back to Search Results
Model Number 30ML
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
So far, we haven't received a lot number, so we were unable to fully investigate this incident.However, we have checked the products of the same model, no similar issues were found.Complaints received for this device and reported condition will continue to be tracked and trended.
 
Event Description
Mckesson 30cc syringe that malfunctioned and allowed air to get into our patient's vein.Black stopper inside separaed from the middle pull back base while in use.Patient complained of chest tightness and was ovserved for 2 hours and then to sent to er.
 
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Type of Device
SYRINGE, PISTON
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 Key18523311
MDR Text Key332975903
Report Number3005670221-2022-00006
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2022
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 Number30ML
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/28/2022
Initial Date FDA Received01/17/2024
Is the Device Single Use? Yes
Patient Sequence Number1
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