BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 7889126 · Received September 19, 2018

    Report

    Report Number
    3009081593-2018-00061
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 28, 2018
    Report Date
    October 1, 2018
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ISSUED A COMPLAINT FOR A MALFUNCTIONED DEVICE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BATCH IS UNKNOWN. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE HAD NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. PMA/510(K)#: K011369, K122558. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE HAD NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729965 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other