BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 22X1 RB

    MDR report key: 11108356 · Received January 4, 2021

    Report

    Report Number
    1213809-2020-00941
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903095728
    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

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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 WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1 RB HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309572 BATCH ,NO.: 0071482. IT WAS REPORTED THAT 4 SYRINGES WERE MISSING 1 EMPTY SEALED BAG, AND SCALE PRINTING IS POOR. CUSTOMER RESPONSE: THE VETERINARY PRACTICES HAS INFORMED OUR QUEBEC CONTACT THAT THE LOT AND EXPIRY DATE IS THE SAME AS THE ONE IN MY EMAIL. WE HAVE ASKED THEM TO PUT THE REMAINING 2 BOXES ASIDE. PER EMAIL: WE HAVE A CUSTOMER THAT IS REPORTING ISSUES WITH YOUR BD 3ML 22GX1'' PRODUCT. THEY HAVE INDICATED THAT OUT OF THE BOX OF 100 UNITS, 4 SYRINGES WERE MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 3ML LL W/NDL 22X1 RB HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309572 BATCH NO.: 0071482. IT WAS REPORTED THAT 4 SYRINGES WERE MISSING 1 EMPTY SEALED BAG, AND SCALE PRINTING IS POOR. CUSTOMER RESPONSE: THE VETERINARY PRACTICES HAS INFORMED OUR QUEBEC CONTACT THAT THE LOT AND EXPIRY DATE IS THE SAME AS THE ONE IN MY EMAIL. WE HAVE ASKED THEM TO PUT THE REMAINING 2 BOXES ASIDE. PER EMAIL: WE HAVE A CUSTOMER THAT IS REPORTING ISSUES WITH YOUR BD 3ML 22GX1'' PRODUCT. THEY HAVE INDICATED THAT OUT OF THE BOX OF 100 UNITS, 4 SYRINGES WERE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11272 SYRINGE 3ML LL W/NDL 22X1 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0071482 00382903095728

    Patients

    Seq Age Sex Outcome Treatment
    1