BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP. 22 G X 1 IN BD ECLIPSE¿ NEEDLE

    MDR report key: 7080779 · Received December 4, 2017

    Report

    Report Number
    9617032-2017-00481
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    April 24, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. IT IS CORRECTED TO READ K022426.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. BD HAD NOT RECEIVED ANY SAMPLE OR PHOTO FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED FOR THE INCIDENT LOT AND NO ISSUES WERE OBSERVED. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE DUE TO A LACK OF OBJECTIVE EVIDENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD SPLATTERED FROM A 3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP. 22 G X 1 IN BD ECLIPSE¿ NEEDLE AFTER BLOOD COLLECTION. THE BLOOD HAD BEEN SPLASHED FROM THE NEEDLE TIP AND BLOOD GOT ONTO THE NURSE'S CLOTH. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859496 3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP. 22 G X 1 IN BD ECLIPSE¿ NEEDLE BLOOD COLLECTION SET JKA BECTON, DICKINSON AND COMPANY (BD) 6232822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other