BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB

    MDR report key: 8961233 · Received September 4, 2019

    Report

    Report Number
    1213809-2019-00886
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 15, 2019
    Report Date
    October 16, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059042
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED A SINGLE 3ML SYRINGE WITH A PART OF ATTACHED RED NEEDLE VISIBLE. THE SYRINGE HAD APPROXIMATELY ½ ML OF MEDICATION IN THE FLUID PATH. A CURLED GREY PIECE OF FOREIGN MATTER WAS OBSERVED TO BE IN THE FLUID PATH, APPEARING TO BE ABOVE THE STOPPER CENTER. BASED ON THE PHOTOS OBSERVED, THE FOREIGN MATTER DOES NOT APPEAR TO BE A PART OF THE STOPPER. IT IS POSSIBLE THAT IT IS A PIECE OF THE SEPTUM FROM THE VACCINE VIAL WHEN IT WAS PUNCTURED WITH THE NEEDLE AND WAS DRAWN UP ALONG WITH THE MEDICATION. PHYSICAL SAMPLE OF THE SYRINGE, NEEDLE AND THE VIAL WOULD BE REQUIRED TO CONFIRM THE TYPE OF FOREIGN MATTER OBSERVED AND THE POTENTIAL ROOT CAUSE. THE DEFECT COULD NOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING PLANT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE APPEARS TO BE A FOREIGN PIECE OF PLASTIC IN SYRINGE. PER CUSTOMER EMAIL: REPORTED ISSUE: ONE OF THE MAS SHOWED ME A BD SYRINGE WITH MMR VACCINE DRAWN UP THAT APPEARS TO HAVE A FOREIGN PIECE OF PLASTIC IN IT. WE CANNOT BE SURE WHERE IT IS FROM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. PMA/510(K)#: K980987 / K951254. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE APPEARS TO BE A FOREIGN PIECE OF PLASTIC IN SYRINGE. PER CUSTOMER EMAIL: REPORTED ISSUE: ONE OF THE MAS SHOWED ME A BD SYRINGE WITH MMR VACCINE DRAWN UP THAT APPEARS TO HAVE A FOREIGN PIECE OF PLASTIC IN IT. WE CANNOT BE SURE WHERE IT IS FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754412 SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9143540 30382903059042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other