BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE SMALL BORE EXTENSION SETS

    MDR report key: 3932290 · Received April 4, 2014

    Report

    Report Number
    9614279-2014-00013
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 11, 2014
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INC. (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVAL COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE DHR RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO NON-CONFORMANCES OR ABNORMALITIES WERE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. 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: REPORTS THE SET LEAKED AT THE Y-SITE CAUSING A CHEMO SPILL. THE CHEMO MEDICATION USED WAS METHOTREXATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205752 CARESITE SMALL BORE EXTENSION SETS SMALLBORE Y-EXTENSION SET W/2 CARESITES FPA B. BRAUN OF DOMINICAN REPUBLIC NA 0061345545

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK