BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 8147206 · Received December 10, 2018

    Report

    Report Number
    3009081593-2018-00076
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 22, 2018
    Report Date
    December 17, 2018
    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. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. 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 PLASTIC CAP CAME OFF WITHOUT THE GRAY CAP AND WOULDN'T ALLOW THE NEEDLE TO INJECT THE PATIENT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369, K122558. 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 PLASTIC CAP CAME OFF WITHOUT THE GRAY CAP AND WOULDN'T ALLOW THE NEEDLE TO INJECT THE PATIENT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988884 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 7114347 00382904745035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other