BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 8475029 · Received April 2, 2019

    Report

    Report Number
    3009081593-2019-00124
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 12, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    UDI-DI
    00382904745035
    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

    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 A SAFETY FAILURE BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSED DOSE OF THE COSENTYX DUE TO A DAMAGED PFS, SPRING WAS OUT OF THE PREFILLED SYRINGE DEVICE UPON OPENING THE PACKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA / 510(K) #: K011369, K122558. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE HAD A SAFETY FAILURE BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSED DOSE OF THE COSENTYX DUE TO A DAMAGED PFS, SPRING WAS OUT OF THE PREFILLED SYRINGE DEVICE UPON OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265353 BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) UNKNOWN 00382904745035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other