BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-DEHP CL BURETROL (BALL VALVE DRIP CHMBR) SET W/2YS 60DPM

    MDR report key: 1812813 · Received August 24, 2010

    Report

    Report Number
    6000001-2010-02713
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE COMPANION UNIT WAS RECEIVED FOR EVALUATION PURPOSES RELATED TO CRACKED/BROKEN CONDITION. UNIT WAS VISUALLY INSPECTED AND DID NOT PRESENT ANY DEFECTS. DEVICE WAS PRESSURE TESTED AT 8PSI AND CLEAR PASSAGE WAS OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO ABERRANCIES FOUND DURING THE MANUFACTURING OF THIS LOT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BURETTE CHAMBER OF THE CLEARLINK BURETROL SOLUTION SET CRACKED WHEN PRIMING. THE NURSE WAS ATTEMPTING TO PRIME AN UNKNOWN CHEMOTHERAPY DRUG BY SQUEEZING THE BURETTE CHAMBER OF THE PRODUCT AND IT CRACKED LENGTHWISE. THERE WAS NO LEAK, BUT THE PRODUCT WAS REPLACED AND IT THEN WORKED FINE. THE CUSTOMER HAS BEEN INFORMED BY THE BAXTER SALES REPRESENTATIVE (BSR), DURING AN ONSITE VISIT ON (B)(6) 2010, THAT PER THE LABEL COPY, THE DRIP CHAMBER SHOULD BE SQUEEZED TO PRIME AND NOT THE BURETTE CHAMBER. PER THE CUSTOMER, SQUEEZING THE BURETTE CHAMBER TO PRIME IS COMMON PRACTICE AT THEIR FACILITY. THE BSR REVIEWED THE LABEL COPY WITH THE CUSTOMER AND REQUESTED ONLY THE DRIP CHAMBER BE SQUEEZED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-DEHP CL BURETROL (BALL VALVE DRIP CHMBR) SET W/2YS 60DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR09H11175

    Patients

    Seq Age Sex Outcome Treatment
    1