BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35C

    MDR report key: 7077361 · Received December 1, 2017

    Report

    Report Number
    3003152976-2017-00141
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 4, 2017
    Report Date
    December 4, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONG
    UDI-DI
    30382905150044
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 510K WAS FOUND FOR THIS PRODUCT. THE CORRECT 510K IS K123213.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY REVIEW WAS NOT CONDUCTED BECAUSE A LOT NUMBER COULD NOT BE DETERMINED. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SAFETY FAILURE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35C. THE NEEDLE OF THE PRODUCT FAILED TO BE COVERED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853342 BD PHASEAL¿ INJECTOR LUER LOCK N35C INJECTOR ONG BECTON DICKINSON, S.A. UNKNOWN 30382905150044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other