BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 30X1/2

    MDR report key: 18236968 · Received November 30, 2023

    Report

    Report Number
    2243072-2023-02116
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 3, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903057574
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT. DEVICE PROBLEM CODE: A140901 - COMPLETE BLOCKAGE.

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. CURRENT CONTROL THERE IS A VISUAL INSPECTION ON CLOGGED NEEDLE AT THE QA OUTGOING INSPECTION PER MQA-052/A AND VISUAL INSPECTION ON CLOGGED NEEDLE AT THE ASSEMBLY IN-PROCESS INSPECTION PER MFG-043/I. ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    MATERIALS#: 305757 BATCH#: 2341255. IT WAS REPORTED BY THE CUSTOMER THAT INSTANT BLOCKAGE WHEN TRYING TO ADMINISTER MEDICINE THROUGH NEEDLE. VERBATIM: INSTANT BLOCKAGE WHEN TRYING TO ADMINISTER MEDICINE THROUGH NEEDLE.

    Description of Event or Problem · 0

    MATERIALS#: (B)(4) BATCH#: 2341255 IT WAS REPORTED BY THE CUSTOMER THAT INSTANT BLOCKAGE WHEN TRYING TO ADMINISTER MEDICINE THROUGH NEEDLE. VERBATIM: INSTANT BLOCKAGE WHEN TRYING TO ADMINISTER MEDICINE THROUGH NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940730 NEEDLE ECLIPSE 30X1/2 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 2341255 30382903057574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown