BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 13261367 · Received January 14, 2022

    Report

    Report Number
    3002682307-2021-00691
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 21, 2021
    Report Date
    April 13, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 30773919 AND LOT NUMBER 2012126. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE SHELF CARTONS WERE OBSERVED WITHOUT THE LABELS. IT HAS BEEN CONCLUDED THAT THE MISSING LABELS RESULTED FROM AN UNEXPECTED AND TEMPORARY PROBLEM WITH THE PRINTING SYSTEM OF THE SECONDARY PACKAGING MACHINE. DURING THE PRINTING PROCESS FOR THE SHELF CARTON LABEL, A MISALIGNMENT OF THE PRINTER SYSTEM CAUSED AN INCORRECT PRINT.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NUMBER: (B)(6). 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 · 0

    IT WAS REPORTED THAT 400 BD EMERALD¿ SYRINGES HAD NO LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MATERIALS TEACHER FOUND THAT THERE WAS NO PRODUCT LABEL ATTACHED TO THE MIDDLE PACKAGE. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 400 BD EMERALD¿ SYRINGES HAD NO LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MATERIALS TEACHER FOUND THAT THERE WAS NO PRODUCT LABEL ATTACHED TO THE MIDDLE PACKAGE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692760 BD EMERALD¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown