BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM NEEDLE-FREE SYRINGE 10ML

    MDR report key: 9631853 · Received January 27, 2020

    Report

    Report Number
    9616066-2020-00284
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Report Date
    January 10, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K071108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT GRID REVISE-SUSPECT CHANGED TO FROM CAD NFV TO MY8010: ADDITIONAL INFORMATION ADDED TO: D1, D2, D4, & G5. THE CUSTOMER¿S REPORT OF OF TEXIUM SYRINGE LOOKED TO BE DISCOLORED WAS NOT CONFIRMED, HOWEVER; THE LUER LOCK TIP SNAPPED OFF WAS CONFIRMED. A PHOTO PROVIDED BY THE CUSTOMER OBSERVED A BREAKAGE FROM THE COLLAR TO THE SYRINGE. THE BROKEN OFF "COLLAR" PIECE WAS STILL AFFIXED ONTO THE TEXIUM CONNECTOR THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE DRAWING CHEMOTHERAPY, THE 10ML TEXIUM SYRINGE LUER LOCK BARREL APPEARED TO BE DISCOLORED. WHEN THE CHEMOTHERAPY WAS REMOVED FROM THE SYRINGE, THE LUER LOCK TIP SNAPPED OFF OF THE END OF THE BARREL WITH MINOR PRESSURE APPLIED. THIS OCCURRED IN THE PHARMACY THEREFORE; THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRAWING CHEMOTHERAPY, THE 10ML TEXIUM SYRINGE LUER LOCK APPEARED DISCOLORED. THE CHEMOTHERAPY WAS REMOVED FROM THE SYRINGE AND THE LEUR LOCK TIP SNAPPED OFF OF THE END OF THE BARREL WITH MINOR AMOUNT OF PRESSURE APPLIED. THERE WAS NOT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95171 TEXIUM NEEDLE-FREE SYRINGE 10ML SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MY8010

    Patients

    Seq Age Sex Outcome Treatment
    1