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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT 3 AND 10 ML NS SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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CARDINAL HEALTH, INC. MONOJECT 3 AND 10 ML NS SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 8881570123
Device Problems Device Slipped (1584); Priming Problem (4040); Air/Gas in Device (4062)
Patient Problem Insufficient Information (4580)
Event Date 06/08/2021
Event Type  malfunction  
Event Description
Syringe plunger slides back allowing syringe to de-prime and fill with air if positive pressure is not maintained.3 ml and 10 ml covidien prefilled ns syringes are at issue.After removing the cap and breaking the seal to remove the small air bubble if constant pressure is not held on the plunger, the plunger slides backward when the syringe is held vertical, allowing the syringe to de-prime and fill with air.Nurses have to keep constant pressure on the plunger while attaching to connector/tubing to prevent air from entering the connection and potential bolus to the patient.Cardinal health contacted, in which they acknowledged this occurrence.Plan is to submit 1-2 unused syringes for their evaluation.No harm has occurred that we are aware of, but the potential is great.
 
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Brand Name
MONOJECT 3 AND 10 ML NS SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
CARDINAL HEALTH, INC.
15 hampshire street
mansfield MA 02048
MDR Report Key12098926
MDR Text Key259469725
Report Number12098926
Device Sequence Number1
Product Code NGT
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
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8881570123
Device Catalogue Number8881570123
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2021
Event Location Hospital
Date Report to Manufacturer07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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