BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML E/T WITH US GRAPHICS

    MDR report key: 10160191 · Received June 16, 2020

    Report

    Report Number
    8041187-2020-00340
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 25, 2020
    Report Date
    June 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903054825
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THESE PHOTOS, THE DAMAGED PACKAGED WAS NOT ABLE TO BE CONFIRMED, THEREFORE THE INCIDENT COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(4) SYRINGES 10ML E/T WITH US GRAPHICS HAD POOR PACKAGE STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PACKAGES WERE RECEIVED DAMAGED AS THE PAPER APPEARED TO NOT REACT WELL WITH THE STERILIZATION PROCESS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: QUICK QUESTION, A CUSTOMER RECEIVED SYRINGE 305482 WHERE THE PAPER DID NOT REACT WELL TO THE STERILIZATION PROCESS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. OCCUPATION: SENIOR SPECIALIST, QUALITY ASSURANCE AND REGULATORY AFFAIRS. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 25 SYRINGES 10ML E/T WITH US GRAPHICS HAD POOR PACKAGE STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PACKAGES WERE RECEIVED DAMAGED AS THE PAPER APPEARED TO NOT REACT WELL WITH THE STERILIZATION PROCESS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: QUICK QUESTION, A CUSTOMER RECEIVED SYRINGE 305482 WHERE THE PAPER DID NOT REACT WELL TO THE STERILIZATION PROCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624559 SYRINGE 10ML E/T WITH US GRAPHICS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 305482 8142303 30382903054825

    Patients

    Seq Age Sex Outcome Treatment
    1 Other