BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ECCENTRIC LUER SLIP TIP SYRINGE

    MDR report key: 16018267 · Received December 20, 2022

    Report

    Report Number
    3003152976-2022-00576
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 29, 2022
    Report Date
    February 17, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008667
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 12-JAN-2023 . H6: INVESTIGATION SUMMARY ONE PHYSICAL SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BLACK PARTICLE WAS IDENTIFIED INSIDE THE SYRINGE. FURTHER EVALUATION IDENTIFIED THE PARTICLE WAS A STOPPER FLAP THAT WAS DETACHED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2112098, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS COMPONENT IS PROVIDED BY AN EXTERNAL SUPPLIER, INCOMING INSPECTIONS ARE PERFORMED ACCORDING TO PROCEDURE. WE HAVE NOTIFIED THE SUPPLIER OF THIS INCIDENT. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME, THEREFORE IT IS LIKELY THE INCIDENT IS RELATED TO AN ISSUE WITH THE MATERIAL PROVIDED BY THE SUPPLIER.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT THE BD¿ ECCENTRIC LUER SLIP TIP SYRINGE STOPPER PEELED OFF WITHIN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM MANDARIN CHINESE TO ENGLISH: THERE SEEMS A PIECE OF STOPPER PEELED OFF WITHIN THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ECCENTRIC LUER SLIP TIP SYRINGE STOPPER PEELED OFF WITHIN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM MANDARIN CHINESE TO ENGLISH: THERE SEEMS A PIECE OF STOPPER PEELED OFF WITHIN THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747427 BD¿ ECCENTRIC LUER SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2112098 00382903008667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown