BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM CLOSED MALE LUER

    MDR report key: 5729427 · Received June 16, 2016

    Report

    Report Number
    9616066-2016-00804
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    May 20, 2016
    Report Date
    June 2, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT A SYRINGE LEAKED DURING AN IV PUSH WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT THE DISTAL HUB OF THE 1ML SYRINGE WAS BROKEN OFF INTO 3 PIECES AND THE EDGES WERE JAGGED. THREE VERTICAL CRACKS WERE OBSERVED ON THE WHITE FEMALE LUER BODY (FLB) OF THE TEXIUM CONNECTOR. THE CRACKS EXTENDED ALMOST COMPLETELY FROM THE PROXIMAL FEMALE END TO THE DISTAL END OF THE FLB AND COMPLETELY FROM THE INTERIOR TO THE EXTERIOR OF THE FLB. THERE WAS NO EVIDENCE OF TOOL MARKS. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RECEIVED PRODUCTS. THE ROOT CAUSE WAS IDENTIFIED TO BE OVER-TORQUE EXERTED DURING USE, CAUSING THE CRACKING OF THE TEXIUM BODY AND THE SYRINGE MALE LUER HUB, RESULTING IN THE LEAK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING OF TESTOSTERONE 150MG, 0.75ML DURING AN IV PUSH. ALTHOUGH THE PATIENT DID NOT RECEIVE THE ENTIRE DOSE AND IT WAS NOT KNOWN HOW MUCH OF THE DOSE WAS ACTUALLY RECEIVED, THERE WAS NO REPORT OF PATIENT OR PROVIDER HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING OF AN UNSPECIFIED MEDICATION DURING AN IV PUSH. THERE WAS NO REPORT OF PATIENT OR PROVIDER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383290 TEXIUM CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10012241-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR