BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 10052118 · Received May 13, 2020

    Report

    Report Number
    3002682307-2020-00154
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    February 5, 2020
    Report Date
    May 20, 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 SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901122 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 NOT AVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO DEFECTS WERE OBSERVED. ALTHOUGH AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT WITHOUT THE DEFECTIVE SAMPLE FOR ANALYSIS, IT IS POSSIBLE THAT THE DEFECT OCCURRED WITHIN THE ASSEMBLY PROCESS WHEN THE ADHESIVE WAS ADDED. EVERY THIRTY MINUTES, THE CLOG CONDITION IS VISUALLY INSPECTED BY THE MACHINE OPERATOR WITH ADDITIONAL IN-COMING INSPECTIONS OF EACH BATCH PERFORMED. WE ARE CONFIDENT THAT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF THE BD¿ SYRINGE WAS FOUND BLOCKED BEFORE USE WHEN ATTACHING IT TO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSE USED THE SYRINGE TO FILL THE MEDICINE FOR THE PATIENT, WHEN SHE OPENED THE 5ML SYRINGE AND ATTACHED THE NEEDLE, SHE FOUND THAT THE NEEDLE WAS BLOCKED".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE BD¿ SYRINGE WAS FOUND BLOCKED BEFORE USE WHEN ATTACHING IT TO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NURSE USED THE SYRINGE TO FILL THE MEDICINE FOR THE PATIENT, WHEN SHE OPENED THE 5ML SYRINGE AND ATTACHED THE NEEDLE, SHE FOUND THAT THE NEEDLE WAS BLOCKED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518295 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other