BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PULSATOR PLUS ARTERIAL BLOOD SAMPLING

    MDR report key: 2004618 · Received February 25, 2011

    Report

    Report Number
    2183502-2011-00051
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 24, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    PMA / PMN Number
    K952516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TWO UNUSED SAMPLES FROM LOT NUMBER 1865056 WERE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LOT NUMBER OF THE RETURNED DEVICES AND NO RELATED NONCONFORMANCES WERE IDENTIFIED DURING MANUFACTURING. THE SYRINGES SAMPLED DURING MANUFACTURING WERE FOUND TO PASS THE TIME-FILL TESTING. THE UNUSED RETURNED PRODUCTS WERE ROUND TO MEET WITH SPECIFICATIONS DURING FILL TESTING. ONCE THE SYRINGES HAD BEEN FILLED AND THE ATTACHED NEEDLES WITHDRAWN, THE REPORTED ISSUE (SQUIRTING OF FLUID) COULD NOT BE CONFIRMED DURING TESTING. THE REPORTED ISSUE COULD NOT BE CONFIRMED TO HAVE BEEN DEVICE-CAUSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE SYRINGE DID NOT WITHDRAW WITH BLOOD PRESSURE BUT REQUIRED USER TO MANUALLY WITHDRAW THE SYRINGE. ACCORDING TO THE REPORTER, WHEN THE ATTACHED NEEDLE WAS WITHDRAWN, BLOOD SQUIRTED OUTSIDE OF THE SYRINGE RESULTING IN SPILL ON PATIENT. NO ADVERSE EFFECTS TO USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX PULSATOR PLUS ARTERIAL BLOOD SAMPLING JKA - BLOOD SAMPLING KIT, ARTERIAL JKA SMITHS MEDICAL ASD, INC. NA 1865056

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK