BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 8504132 · Received April 11, 2019

    Report

    Report Number
    3002682307-2019-00244
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 16, 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
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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. BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 300928 LOT 1901281 TO INVESTIGATE FOR THIS RECORD. THE PHOTO CLEARLY SHOWS BLOOD SPLATTER ON THE ADMIN'S DRESSING. AS A RESULT, BD IS ABLE TO VERIFY THE REPORTED ISSUE. UNFORTUNATELY, BECAUSE THE SAMPLE WAS NOT AVAILABLE OR PICTURED, A DEFINITIVE ROOT CAUSE OF THE ISSUE IS UNABLE TO BE DETERMINED AT THIS TIME. A PROBABLE CAUSE COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE BARREL WALL. THAT DAMAGE WAS PRODUCED DURING THE MARKING PROCESS OF THE BARREL IN THE ASSEMBLY MACHINE, DUE TO A MISALIGNMENT OF THE MARKING SYSTEM OF MACHINE. THIS ISSUE WAS FOUND DURING PRODUCTION OF ASSEMBLY LOT #9021578, THE SEGREGATION OF THE PRODUCT WAS NOT CORRECTLY DONE BY THE OPERATOR AND THE PRESENCE OF ONE SYRINGE WITH THIS LEAKAGE ISSUE WAS NOT PROPERLY AVOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD SPLATTERED FROM THE BD DISCARDIT¿ II SYRINGE AND ONTO THE NURSE'S CLOTHING BEFORE IT COULD BE INJECTED INTO A "HEMOCULTURE FLASK". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "THERE WAS A SPLATTER WHEN THE NURSE WAS ABOUT TO INJECT THE BLOOD INTO A HEMOCULTURE FLASK."

    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 BLOOD SPLATTERED FROM THE BD DISCARDIT¿ II SYRINGE AND ONTO THE NURSE'S CLOTHING BEFORE IT COULD BE INJECTED INTO A "HEMOCULTURE FLASK". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THERE WAS A SPLATTER WHEN THE NURSE WAS ABOUT TO INJECT THE BLOOD INTO A HEMOCULTURE FLASK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297744 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1901281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other