BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD NEEDLE

    MDR report key: 19095651 · Received April 12, 2024

    Report

    Report Number
    2243072-2024-00542
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 22, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS NO MATERIAL AND BATCH/LOT NUMBER WAS PROVIDED. A DEVICE HISTORY REVIEW CANNOT BE PERFORMED AS NO MATERIAL AND BATCH/LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL#: UNKNOWN , BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED MORE COMPLAINTS FROM THEIR CUSTOMERS. VERBATIM: RCC RECEIVED THIS MAIL ON 22-MAR-2024. WE JUST RECEIVED MORE COMPLAINTS FROM CUSTOMERS TODAY. WE NEED TO BE ABLE TO SEND SAMPLES BACK SO AN RMA AND RETURN LABEL WOULD BE APPRECIATED SO WE CAN DO THAT. RCC RECEIVED THIS MAIL ON 19-MAR-2024. WE ARE AWAITING ANY INFORMATION REGARDING THIS ISSUE. IF THE PRODUCT IS BLOCKED THAT MAKES THE PRODUCT UNUSABLE AND THAT PRESENTS A FUNCTIONALITY ISSUE. I WOULD ASSUME YOU ARE PUTTING THESE INTO FINISHED PRODUCT OF YOUR OWN, SO A CORRECTIVE ACTION SEEMS NECESSARY.

    Description of Event or Problem · 0

    MATERIAL#: UNKNOWN, BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED MORE COMPLAINTS FROM THEIR CUSTOMERS. VERBATIM: RCC RECEIVED THIS MAIL ON 22-MAR-2024. WE JUST RECEIVED MORE COMPLAINTS FROM CUSTOMERS TODAY. WE NEED TO BE ABLE TO SEND SAMPLES BACK SO AN RMA AND RETURN LABEL WOULD BE APPRECIATED SO WE CAN DO THAT. RCC RECEIVED THIS MAIL ON 19-MAR-2024. WE ARE AWAITING ANY INFORMATION REGARDING THIS ISSUE. IF THE PRODUCT IS BLOCKED THAT MAKES THE PRODUCT UNUSABLE AND THAT PRESENTS A FUNCTIONALITY ISSUE. I WOULD ASSUME YOU ARE PUTTING THESE INTO FINISHED PRODUCT OF YOUR OWN, SO A CORRECTIVE ACTION SEEMS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837068 UNKNOWN BD NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown