BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 9970798 · Received April 17, 2020

    Report

    Report Number
    2243072-2020-00620
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG OR A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT, AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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¿T BE DETERMINED AS NO SAMPLES WERE RECEIVED. .A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. ROOT CAUSE DESCRIPTION: UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFECTIVE STOPPER WAS FOUND DURING USE WITH A UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DESCRIPTION OF ISSUE: CUSTOMER REPORTED NOT BEING ABLE TO DRAW INSULIN INTO THE SYRINGE, CUSTOMER ALSO REPORTED ISSUE WITH BLACK RUBBER FROM PLUNGER BEING MISSHAPED." 4 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435593 UNSPECIFIED BD SYRINGE UNKNOWN FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other