BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 2052038 · Received March 2, 2011

    Report

    Report Number
    2242445-2011-00028
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3ML NIPRO SYRINGE IN THE KIT IS BEING DESCRIBED AS VERY LOOSE AND ALLOWING AIR BUBBLES INTO THE SYRINGE. SEVERAL ATTEMPTS WERE MADE TO USE THE DEVICE, BUT THEY WERE UNSUCCESSFUL. ANOTHER SEPARATE SYRINGE WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY IN TREATMENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE SALES REPRESENTATIVE STATED THAT HE HAD THEM OPEN A KIT AND COULD NOT TELL ANYTHING WAS WRONG WITH THE SYRINGE. HE ALSO CHECKED ON THEIR CENTRAL LINE KITS WHICH USE THE SAME SYRINGES, IN OTHER AREAS OF THE HOSPITAL AND COULD NOT FIND ANY PROBLEMS WITH THE END USERS. THIS PARTICULAR PHYSICIAN DOES NOT LIKE THIS SYRINGE AND THE SALES REPRESENTATIVE FEELS IT IS A CUSTOMER PREFERENCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTERNATIONAL, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN