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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT SYRINGE, PISTON

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CARDINAL HEALTH, INC. MONOJECT SYRINGE, PISTON Back to Search Results
Model Number 1186000777
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 11/05/2020
Event Type  malfunction  
Event Description
Shortly after change of shift it was noted that the lipids line was wet. Tracing back up to the spot where the syringe was screwed into the line's hub there was a large amount of leakage. End of syringe was broken. Lipids were stopped and disconnected from patient. Nurse practitioner was made aware. Pharmacy was contacted. After checking in with the pharmacy again they stated that it was all prepared under a hood to maintain sterility so the whole set up (tpn, total parenteral nutrition, included) would need to be redone. Nurse practitioner made aware, stated that patient could go without lipids infusing for the night.
 
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Brand NameMONOJECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH, INC.
1222 sherwood rd
norfolk NE 68701
MDR Report Key11321032
MDR Text Key231588572
Report Number11321032
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 Other Health Care Professional
Type of Report Initial
Report Date 02/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1186000777
Device Catalogue Number1186000777
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/05/2021
Event Location Hospital
Date Report to Manufacturer02/12/2021
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? No
Type of Device Usage Unkown

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