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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT HYPODERMIC NEEDLES AND SYRINGES SYRINGE, PISTON

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CARDINAL HEALTH MONOJECT HYPODERMIC NEEDLES AND SYRINGES SYRINGE, PISTON Back to Search Results
Model Number 1180300777
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
Per doctors orders mmr (measles, mumps, and rubella) vaccine was given but the mmr vaccine leaked from the connection of the needle and syringe. I informed mother and doctor of the incident and both agree to repeat the mmr vaccine injection due to patient not received of the first mmr vaccine.
 
Event Description
Per doctors orders mmr (measles, mumps, and rubella) vaccine was given but the mmr vaccine leaked from the connection of the needle and syringe. I informed mother and doctor of the incident and both agree to repeat the mmr vaccine injection due to patient not received of the first mmr vaccine.
 
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Brand NameMONOJECT HYPODERMIC NEEDLES AND SYRINGES
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH
3651 birchwood drive
waukegan IL 60085
MDR Report Key11693146
MDR Text Key246272237
Report Number11693146
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1180300777
Device Catalogue Number1180300777
Device Lot Number029354
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/2021
Event Location Other
Date Report to Manufacturer04/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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