BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM CLOSED MALE LUER WITH FEMALE CAP

    MDR report key: 3063185 · Received March 27, 2013

    Report

    Report Number
    9616066-2013-00214
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K053049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE TEXIUM CAP LEAKED IVF (CHEMO) FROM WHERE THE CAP CONNECTS TO THE SECONDARY SET. THIS WAS OBSERVED AFTER SEVERAL HOURS OF USE, WHEN THE RN WENT TO HANG ANOTHER MEDICATION. THE RN TRIED UN-CONNECTING AND RE-TIGHTENING THE CONNECTION, BUT IT CONTINUED TO LEAK AT THE CONNECTION SITE. THE SITE WAS REPLACED BEFORE THE NEXT CHEMO ADMINISTRATION. THE EVENT OCCURRED ON INPT WARD/RESIDENT UNIT, BCCH ONCOLOGY/HEMATOLOGY/MBT PROGRAM. THE PT SAFETY LEARNING SYSTEM FORM (B)(4) INDICATED THAT NO HARM HAD COME TO THE PT, NOR WAS THERE ANY LIKELIHOOD HARM IF THERE HAD BEEN A RECURRENCE. NO FURTHER PT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124905 TEXIUM CLOSED MALE LUER WITH FEMALE CAP FPA CAREFUSION CORP 10012241-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY SET: MFR, MODEL/LOT # UNK