BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD EXTENSION SET WITH CARESITE®

    MDR report key: 6046882 · Received October 21, 2016

    Report

    Report Number
    9614279-2016-00072
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    September 26, 2016
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    PMA / PMN Number
    K153293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH SAMPLE ANALYSIS OR BATCH RECORD REVIEW 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 REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REPORTS AIR BUBBLES IN THE TUBING. FOLLOW-UP CORRESPONDENCE WITH THE REPORTER INDICATED THAT THE AIR BUBBLES SEEN IN THE TUBING RANGED IN SIZE (BOTH LARGE AND SMALL BUBBLES WERE SEEN). NORMAL SALINE SOLUTION WAS IN THE LINE AT THE TIME. THE SET WAS CONNECTED TO A HOSPIRA PRIMARY PLUMSET (ITEM # (B)(4); HOWEVER, THE AIR BUBBLES WERE ONLY SEEN IN THE B. BRAUN EXTENSION SET. THE RN'S TRIED FLICKING AND NOT FLICKING THE LUER ACCESS DEVICES DURING PRIMING WITH THE SAME RESULTS. THE RN'S INDICATED THAT THEY WASTED ABOUT 50ML OF SALINE JUST TRYING TO GET MOST OF THE BUBBLES OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698107 STANDARD EXTENSION SET WITH CARESITE® STANDARD EXTENSION SET WITH CARESITE VALVE FPA B. BRAUN DOMINICAN REPUBLIC INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 HOSPIRA PRIMARY PLUMSET (ITEM # (B)(4)