BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRASITE ADDITIV PRIMARY I.V.SET

    MDR report key: 1220554 · Received October 29, 2008

    Report

    Report Number
    9614279-2008-00042
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K790062
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES IN THE INCIDENTS HAVE NOT YET BEEN RETURNED TO THE MANUFACTURER TO BE EVALUATED. THIRTY-ONE (31) UNUSED REPRESENTATIVE SAMPLES SEALED IN THE BLISTER PACKAGE FROM THE REPORTED LOT WERE RETURNED FOR EVALUATION. THE THIRTY ONE UNUSED SAMPLES WERE PHYSICALLY TESTED FOR LEAKAGE AND WERE FOUND ACCEPTABLE. THE SAMPLES WERE THEN SUBJECTED TO A PULL TEST AT THE BONDED JOINTS. ALL SAMPLES EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION AND PASSED THE JOINT INTEGRITY TEST. THE HOUSE RETAIN SAMPLES FOR THE REPORTED LOT WERE ALSO PHYSICALLY TESTED FOR LEAKAGE AND SUBJECTED TO PULL TEST AT THE BONDED JOINTS. ALL SAMPLES EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION AND PASSED THE JOINT INTEGRITY TEST. WITHOUT THE ACTUAL SAMPLES A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF THE ACTUAL SAMPLES ARE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: TWO INCIDENTS OCCURRED; ONE INCIDENT OCCURED IN 2008 ANOTHER A FEW DAYS EARLIER. INCIDENT REPORTED: TUBING COMING APART AND SPILLAGE OF CHEMOTHERAPY AGENT. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE SETS CAME APART AT THE Y-SITE, LEADING TO CHEMO SPILLS. IT HAS BEEN REPORTED NO ONE SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENTS. ALTHOUGH THE FACILITY RETURNED UNUSED SAMPLES FOR EVALUATION, THE FACILITY REPORTED THEY WILL ALSO BE SENDING THE USED SAMPLES INVOLVED IN THE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE ADDITIV PRIMARY I.V.SET UNIVERSAL I.V. SET FPA B. BRAUN OF DOMINICAN REPUBLIC NA 61002178

    Patients

    Seq Age Sex Outcome Treatment
    1