BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEEDLE 25 X 5 8

    MDR report key: 13097786 · Received December 28, 2021

    Report

    Report Number
    1017768-2021-00996
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    September 16, 2021
    Report Date
    February 2, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    UDI-DI
    10884521000575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR THE POSSIBLE LOT NUMBERS REPORTED INDICATE THERE WERE NO VISUAL OR PHYSICAL ISSUES DETECTED IN THE SAMPLES INSPECTED FOR EITHER LOT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE OF BOTH PHYSICALLY AND VISUALLY. THERE WERE NO SAMPLES OR PHOTOS RECEIVED FOR EVALUATION AT THE MANUFACTURING SITE. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION THERE¿S INSUFFICIENT EVIDENCE AVAILABLE TO DETERMINE A MOST PROBABLE ROOT CAUSE FOR THIS INVESTIGATION. THERE¿S NO INDICATION OF A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS, SO A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WILL NOT BE ISSUED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT WAS RECEIVING A SUBCUTANEOUS INJECTION OF CHEMOTHERAPY (VIDAZA). THE SECOND SYRINGE STARTED TO GET A DROP OF CHEMO COMING OUT OF THE NEEDLE. THE NURSE VERIFIED THE CONNECTION WAS TIGHT AND CONTINUED THE INJECTION WITH A GAUZE ON THE PATIENT AND NOTICED THE DROP CAME OUT FROM THE NEEDLE, NOT THE CONNECTION. THE PHARMACY WAS NOTIFIED. THE LOT NUMBER IS UNKNOWN HOWEVER POSSIBLE LOTS ARE 111923 AND 110967. BOTH EXPIRING 2/28/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989598 SAFETY NEEDLE 25 X 5 8 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 8881850558 10884521000575

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown