BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 12760425 · Received November 7, 2021

    Report

    Report Number
    3002682307-2021-00596
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    August 17, 2021
    Report Date
    October 18, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011204. 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, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE INSPECTED AND NO SIGNS OF DEFECT WERE IDENTIFIED. PER THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. A QUALITY INITIATIVE WAS OPENED WITH THE AIM OF REDUCING THE RECURRENCE OF THIS TYPE OF DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ SYRINGE THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SYRINGE LEAKED WHEN THE LIQUID WAS ASPIRATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658671 BD¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011204

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown