BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 20ML

    MDR report key: 12771766 · Received November 8, 2021

    Report

    Report Number
    3002682307-2021-00600
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    August 31, 2021
    Report Date
    December 3, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2101172. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS COULD BE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE S2 20ML HAD A BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WHEN PREPARING THE CONSUMABLES FOR ROUTINE USE IN THE OPERATING ROOM, IT WAS FOUND THAT THE SYRINGE WAS WEAK IN SUCTION AND THE NEEDLE WAS BLOCKED."

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE S2 20ML HAD A BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN PREPARING THE CONSUMABLES FOR ROUTINE USE IN THE OPERATING ROOM, IT WAS FOUND THAT THE SYRINGE WAS WEAK IN SUCTION AND THE NEEDLE WAS BLOCKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666829 BD SYRINGE S2 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101172

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown