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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP MONOJECT SYRINGE SYRINGE, PISTON

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COVIDIEN LP MONOJECT SYRINGE SYRINGE, PISTON Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  malfunction  
Event Description
Tip of syringe broke off in the syringe pump when registered nurse (rn) was administering iv lipids to a neonate. New dose in syringe sent from pharmacy. Location: neonatal intensive care unit (nicu).
 
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Brand NameMONOJECT SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key7335366
MDR Text Key102366592
Report Number7335366
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/13/2018
Event Location Hospital
Date Report to Manufacturer02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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