BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, RBN-84

    MDR report key: 2917879 · Received December 20, 2012

    Report

    Report Number
    1211566-2012-00005
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 5, 2012
    Manufacturer
    RANFAC CORP.
    Product Code
    KNW
    PMA / PMN Number
    983187
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RANFAC CORPORATION WAS UNABLE TO REPLICATE THE INCIDENT EXPERIENCED BY THE END USER; THEREFORE, UNABLE TO INSTITUTE AN EFFECTIVE PREVENTIVE ACTION.

    Description of Event or Problem · 1

    PHYSICIAN HAD DIFFICULTY RETRIEVING SAMPLE FROM NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE, RBN-84 RBN-84 KNW RANFAC CORP. 74050-06M 24315

    Patients

    Seq Age Sex Outcome Treatment
    1