BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOFIX 4 WAY STOPCOCK

    MDR report key: 2860674 · Received October 29, 2012

    Report

    Report Number
    2523676-2012-00223
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 30, 2012
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K760383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE A LOT NUMBER WAS NOT PROVIDED, A BATCH REVIEW COULD NOT BE PERFORMED. A HISTORICAL REVIEW OF THE PRODUCT INCIDENT REPORT DATABASE, REVEALED NO ADVERSE TRENDS OF THIS NATURE AGAINST FINISHED GOOD #456020. THE ACTUAL STOPCOCK IN THE REPORTED INCIDENT WAS RETURNED FOR EVAL. A VERTICAL CRACK WAS NOTED ON THE FEMALE SIDE PORT OF THE STOPCOCK. THE CRACK APPEARED BE ALONG THE KNIT LINE. SEVERAL STRESS MARKS WERE NOTED AROUND THE DIAMETER OF THE FEMALE SIDE PORT, PARALLEL TO THE KNIT LINE AND IN PROXIMITY TO THE STOPCOCK THREADS. THE SAMPLE AND ALL AVAILABLE INFO HAVE BEEN FORWARDED TO THE ACTUAL MFR FOR FURTHER EVAL. WHEN THE MFR'S EVAL IS COMPLETE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF #456020, LOT #UNK, 1 ITEM, OCCURRED (B)(6) 2012. REPORTS NURSE FOUND ITEM WHICH WAS ATTACHED TO A CENTRAL LINE LEAKING, A LARGE AMOUNT OF TPN AND BLOOD WERE MIXED ON THE BED. STOPCOCK CHANGED TO A NEW ONE. PT DID HAVE A REPEAT CBC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOFIX 4 WAY STOPCOCK DISCOFIX STOPCOCK ASSEMBLY FRN B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other