BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 8197839 · Received December 26, 2018

    Report

    Report Number
    3002682307-2018-00341
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 5, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2022 (MAY 31ST ¿ JUNE 1ST, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4251, Nº4252, Nº4208, AND Nº4204, IN LOT #8148567 (MAY 28TH ¿ JUNE 4TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8149705, #8142763, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8149709, #8142767 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLES. AFTER THE EVALUATION OF THE RETURNED SAMPLES, WE CONFIRMED THE REPORTED ISSUE, AND CONCLUDED THAT THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED OF LUBRICANT FROM THE SYRINGE BARREL. CAPA 207816 HAS BEEN OPENED TO INVESTIGATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHITE PARTICLES" WERE NOTICED SEPARATING FROM THE PLUNGER IN THE DISCARDIT¿ II SYRINGE W/O NEEDLE, AND "WHITE COATING" WAS NOTICED IN THE INNER BARREL.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 "WHITE PARTICLES" WERE NOTICED SEPARATING FROM THE PLUNGER IN THE DISCARDIT¿ II SYRINGE W/O NEEDLE, AND "WHITE COATING" WAS NOTICED IN THE INNER BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035723 DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1805300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other