BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESITE (LAD)

    MDR report key: 3232245 · Received July 8, 2013

    Report

    Report Number
    2523676-2013-00214
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. (B)(4). DURING FOLLOW-UP CORRESPONDENCE WITH THE FACILITY, THE REPORTER STATED THAT THE PATIENT DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION AFTER THE VALVE WAS CHANGED. WHEN ASKED WHAT SHE FELT HAPPENED DURING THE INCIDENT, THE REPORTER STATED THAT THE VALVE WAS NOT 100% THREADED INTO THE I.V. SET BEING USED (BARD MINI LOCK SET). DIFFERENT I.V. SETS ARE IN THE PROCESS OF BEING EVALUATED BY THE FACILITY. NO SAMPLE AVAILABLE FOR EVALUATION. THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308964 CARESITE (LAD) CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R