BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL CONVENIENCE TRAY

    MDR report key: 18489253 · Received January 10, 2024

    Report

    Report Number
    3003152976-2023-00558
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 14, 2023
    Report Date
    February 27, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903022380
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE EMPTY TRAY SAMPLE AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THE PLASTIC TRAY IS DISCOLORED AND DAMAGED. NO HOLES OR PERFORATIONS ARE IDENTIFIED IN THE SAMPLE. THE TRAY WAS PROVIDED OPENED WITHOUT PRODUCT INSIDE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2310017, 2212081 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS INCIDENT CAN BE PRODUCED DURING THERMO-FORMING OF THE FILM FOR THE TRAY OF THE PRODUCT. IF THE FILM IS EXPOSED TO HIGH TEMPERATURE MORE TIME THAN REQUIRED, FILM CAN BE DAMAGED CAUSING THE VISUAL DEFECTS NOTICED IN THE SAMPLES PROVIDED BY CUSTOMER. STERILITY IS NOT COMPROMISED IF THERE IS NO HOLE IN THE TRAY. THE GIVEN SAMPLE WAS INSPECTED NOT FINDING ANY HOLE IN IT. A PROJECT WILL BE INITIATED TO VERIFY IF THE STERILIZATION PROCESS AFFECTS THE ASPECT OF THE TRAY. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50ML LL CONVENIENCE TRAY PACKAGE WAS DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN A TOTAL OF 7 PACKS, THE SECONDARY PACKAGING, I.E. THE CONVENIENCE PACK, WAS DAMAGED AT THE CORNERS. SOME OF THE INNER PLASTIC LAYERS, I.E. THE SIDE WITH WHICH THE SYRINGES COME INTO CONTACT, HAD FLAKED OFF. FROM THE OUTSIDE, THE MATERIAL APPEARED TO HAVE BEEN EXPOSED TO GREATER HEAT. THERE ARE NO HOLES IN THE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647046 BD SYRINGE 50ML LL CONVENIENCE TRAY SYRINGE, PISOTON FMF BECTON DICKINSON 2310017 00382903022380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown