BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 10215874 · Received June 30, 2020

    Report

    Report Number
    3002682307-2020-00204
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 28, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1811191 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF FOREIGN MATTER WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. THERE ARE SEVERAL PREVENTIVE MEASURES IN PLACE TO ENSURE THAT FOREIGN MATTER IS NOT INTRODUCED TO THE PRODUCT. THE ASSEMBLY AND PACKAGING PROCESS TAKE PLACE WITHIN AN ENVIRONMENTALLY CONTROLLED ROOM, WHERE AIR IS CONTINUOUSLY FILTERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND IN THE BD¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THERE WAS BLACK FOREIGN MATTER IN THE PRODUCT AND IT WAS NOT USED. IMMEDIATELY REPLACED OTHER BATCHES OF PRODUCTS, AND THE MANUFACTURING ENTERPRISES ACTIVELY COOPERATE WITH THE HOSPITAL TO ANALYZE THE CAUSE OF THE INCIDENT AND CARRY OUT INTERNAL RECTIFICATION."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND IN THE BD¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THERE WAS BLACK FOREIGN MATTER IN THE PRODUCT AND IT WAS NOT USED. IMMEDIATELY REPLACED OTHER BATCHES OF PRODUCTS, AND THE MANUFACTURING ENTERPRISES ACTIVELY COOPERATE WITH THE HOSPITAL TO ANALYZE THE CAUSE OF THE INCIDENT AND CARRY OUT INTERNAL RECTIFICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680105 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1811191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other