BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 9364541 · Received November 22, 2019

    Report

    Report Number
    3002682307-2019-00623
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 10, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH SAMPLES FOR CATALOG 30774319 LOT 1811360 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION UNDER A MICROSCOPE REVEALED THAT THE CLOG IS PRODUCED BECAUSE OF THE EPOXY USED DURING MANUFACTURING. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM WAS PRODUCED DUE TO SOME PROBLEM IN THE ASSEMBLY PROCESS (FOR EXAMPLE, NOT ENOUGH VACUUM), THE CANNULA WAS NOT PLACED IN THE CORRECT POSITION INTO THE HUB AND, AS A CONSEQUENCE, THE EPOXY USED TO JOIN BOTH PIECES BLOCKED THE CANNULA. EVERY 30 MINUTES, CLOG CONDITION IS VISUALLY INSPECTED BY MACHINE OPERATOR. IN ADDITION, AS IN-COMING INSPECTION EACH CANNULA BATCH IS ALSO INSPECTED BY QUALITY OPERATOR. ALL PRODUCTION AND INSPECTION RECORDS HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NO CHANGES IN THE PROCESS HAVE BEEN IMPLEMENTED WHICH COULD GENERATE THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE NEEDLE WAS CLOGGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENED THE PACKAGE, THE CUSTOMER FOUND THE NEEDLE CLOGGED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE NEEDLE WAS CLOGGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENED THE PACKAGE, THE CUSTOMER FOUND THE NEEDLE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160790 BD EMERALD SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other