BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML EMERALD BNS

    MDR report key: 8786513 · Received July 12, 2019

    Report

    Report Number
    3002682307-2019-00403
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 8, 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
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 303127 LOT 9085974 TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE RETURNED PICTURE PRESENTED A SCRATCHED BARREL WHICH PRODUCED THE SCALE MARKING DAMAGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS CONCLUDED THAT THE DAMAGED BARREL WAS PRODUCED IN THE ASSEMBLY MACHINE. ONCE THE BARREL IS MARKED, THE PLUNGER IS ASSEMBLED TO THE BARREL. IN THAT PROCESS, THE BARREL IS HELD BY A FIXTURE AND BD BELIEVES THAT THE FIXTURE WAS NOT CORRECTLY POSITIONED AND THIS DAMAGED THE BARREL WALL. BD STATES THAT WAS A PUNCTUAL MISALIGNMENT OF THE BARREL FIXING SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A SYRINGE 5ML EMERALD BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PROCESSING OF THIS LOT IN THE PRODUCTION IT WAS IDENTIFIED THAT THE PRINTING IS DAMAGED. ON THE NOK PARTS THERE ARE VISIBLE SCRATCHES / FLASHES ¿ IT WOULD INDICATE THAT PARTS COULD HAVE BEEN DAMAGED DURING CONVEYING PROCESS OR SOMETHING LIKE THAT. WE HAVE DETECTED APPROXIMATELY 500 NOK UNITS WITHIN ONE BAG - OTHER BAGS SEEM TO BE OK SO FAR."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A SYRINGE 5ML EMERALD BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PROCESSING OF THIS LOT IN THE PRODUCTION IT WAS IDENTIFIED THAT THE PRINTING IS DAMAGED. ON THE NOK PARTS THERE ARE VISIBLE SCRATCHES / FLASHES ¿ IT WOULD INDICATE THAT PARTS COULD HAVE BEEN DAMAGED DURING CONVEYING PROCESS OR SOMETHING LIKE THAT. WE HAVE DETECTED APPROXIMATELY 500 NOK UNITS WITHIN ONE BAG - OTHER BAGS SEEM TO BE OK SO FAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580925 SYRINGE 5ML EMERALD BNS SYRINGE/NEEDLE FMF BECTON DICKINSON, S.A. 9085974

    Patients

    Seq Age Sex Outcome Treatment
    1 Other