BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 7397026 · Received April 4, 2018

    Report

    Report Number
    3009081593-2018-00021
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 18, 2018
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: 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. IT SHOULD BE NOTED THAT TESTS PERFORMED BY BD TATABÁNYA DURING PRODUCTION CONTROLS ARE RELATED TO THE ASSEMBLED DEVICE, WITHOUT USING SYRINGE AND PLUNGER ROD. TESTING OF COMBINATION PRODUCT IS OUT OF SCOPE FOR SAFETY DEVICE MANUFACTURING. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 5239129, MEDICAL DEVICE EXPIRATION DATE: 2019-07-31,  DEVICE MANUFACTURE DATE: 2015-08-27. MEDICAL DEVICE LOT #: 5243391, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31,  DEVICE MANUFACTURE DATE: 2015-08-31. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY DEVICE ON A BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE DID NOT ACTIVATE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237848 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE SAFETY SYRINGE WITH NEEDLE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other