BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 24934208 · Received April 21, 2026

    Report

    Report Number
    9680654-2026-00061
    Event Type
    Injury
    Date Received
    April 21, 2026
    Report Date
    April 21, 2026
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    PMA / PMN Number
    K983593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    OVER THE LAST 3 MONTHS, THEY HAD 3 HEMOPERITONEUM WITH THE LAST OCCURRENCE LAST FRIDAY (B)(6) 2026. REP HAS ASKED FOR DATE FOR PREVIOUS INCIDENTS. NEEDLES INVOLVED: K-OSN-1730-B-90. PUMP: K-MAR-5200. THIS (B)(4): 2 EVENTS OF HEMOPERITONEUM. UNKNOWN DATES OF EVENTS, BETWEEN (B)(6) 2026 AND (B)(6) 2026 (REPORTED TO MANUFACTURER ON 14APR 2026 AS BEING 'IN THE PAST 3 MONTHS') K-OSN-1730-B-90 NEEDLES OF UNKNOWN LOT NUMBERS THAT WERE USED WITH COOK MEDICAL K-MAR-5200 PUMP. SEE (B)(4) FOR: HEMOPERITONEUM OCCURRED (B)(6) 2026: K-OSN-1730-B-90 NEEDLE OF UNKNOWN LOT NUMBER THAT WAS USED WITH COOK MEDICAL K-MAR-5200 PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416654 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD K-OSN-1730-B-90

    Patients

    Seq Age Sex Outcome Treatment
    1