BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 10841547 · Received November 15, 2020

    Report

    Report Number
    3002682307-2020-00343
    Event Type
    Malfunction
    Date Received
    November 15, 2020
    Date of Event
    October 19, 2020
    Report Date
    January 11, 2021
    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 1901125 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 EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE DISPENSING PROCESS, IT WAS FOUND THAT THE SEAL WAS NOT TIGHT AND THE LIQUID LEAKED.".

    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 THE BD SYRINGE¿ WITH NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING THE DISPENSING PROCESS, IT WAS FOUND THAT THE SEAL WAS NOT TIGHT AND THE LIQUID LEAKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306857 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901125

    Patients

    Seq Age Sex Outcome Treatment
    1