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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE LL 10CC
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JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE LL 10CC Back to Search Results
Catalog Number 16-S10C
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 12/27/2021
Event Type  malfunction  
Event Description
The customer reported that the plunger of the syringe seems smaller than the barrel and that it leaks.The concern expressed was that it would be tricky to deliver only 1 ml of lidocaine using the syringe.No information was received regarding any serious injury as a result of this product malfunction.
 
Event Description
The customer reported that the plunger of the syringe seems smaller than the barrel and that it leaks.The concern expressed was that it would be tricky to deliver only 1 ml of lidocaine using the syringe.No information was received regarding any serious injury as a result of this product malfunction.
 
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Brand Name
MCKESSON BRANDS
Type of Device
SYRINGE LL 10CC
Manufacturer (Section D)
JIANGSU CAINA MEDICAL CO., LTD.
no. 23 huanxi rd
zhutang town, jiangyin city
CH 
MDR Report Key13293300
MDR Text Key286330863
Report Number1451040-2022-00003
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number16-S10C
Device Lot NumberCJCA08-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/19/2022
Distributor Facility Aware Date12/27/2021
Device Age5 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/19/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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