BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD NEEDLE

    MDR report key: 10709337 · Received October 20, 2020

    Report

    Report Number
    2243072-2020-01687
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 7, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL 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 BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. INVESTIGATION CONCLUSION: MATERIAL NUMBER AND BATCH NUMBER IS UNKNOWN; A LOT HISTORY REVIEW COULD NOT BE PERFORMED. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: CAPA IS NOT REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD NEEDLE BROKE DURING USE. THE FOLLOWING WAS REPORTER BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES HAVE BROKEN DURING LOAD PROCESS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: "CUSTOMER CONTACT STATED SHE HAS BROKEN NEEDLES DURING LOAD PROCESS AND NEEDS SOME REPLACEMENTS. CTS TO SEND BOX OF REPLACEMENTS DUE TO ALARM 8 [COM-812845] AND BROKEN NEEDLES. SEE INTAKE. CUSTOMER ACKNOWLEDGED AND UNDERSTOOD. NO OTHER PUMP ISSUES REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173885 UNSPECIFIED BD NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other