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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MONOJECT SYRINGES

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COVIDIEN MONOJECT SYRINGES Back to Search Results
Device Problems Bent (1059); Loose or Intermittent Connection (1371); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2018
Event Type  malfunction  
Event Description
Several coviden monoject syringes found to be unusable while repackaging morphine for intrathecal use. Plunger tip neither straight, nor secure in barrel causing concern for accuracy and integrity of finished preparation.
 
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Brand NameMONOJECT SYRINGES
Type of DeviceSYRINGES
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key7335428
MDR Text Key102366914
Report Number7335428
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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