BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOFIX D500 4-WAY SPIN-LOCK

    MDR report key: 3080764 · Received April 10, 2013

    Report

    Report Number
    2523676-2013-00094
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 6, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    KGZ
    PMA / PMN Number
    K760383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL, INC INTERNAL REPORT #(B)(4). DURING A F/U CALL WITH THE FACILITIES RISK MGMT GROUP, THE INDIVIDUAL STATED THAT NO ADD'L INFO REGARDING THIS OCCURRENCE WAS AVAILABLE. THE ONLY INFO AVAILABLE IS WHAT WAS REPORTED ON THE MEDWATCH FORM. THE MEDWATCH FORM INDICATES THAT NO SAMPLE OR LOT IS AVAILABLE AND THAT THE INFANT'S HEMATOCRIT REMAINED STABLE POST INCIDENT. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH # (B)(4): PREMATURE INFANT IN THE NICU FOR TREATMENT OF ANEMIA HAD A UVC LINE PLACED. THE UVC LINE STOPCOCK WAS FOUND WITH A CRACK AND PT LOST APPROX 10 CCS OF BLOOD. HCT REMAINED STABLE POST INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153527 DISCOFIX D500 4-WAY SPIN-LOCK 4-WAY STOPCOCK W/ SPINLOCK CONNECTOR KGZ B. BRAUN MEDICAL, INC. D500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other