BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 24934310 · Received April 21, 2026

    Report

    Report Number
    9680654-2026-00062
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    April 10, 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

    Additional Manufacturer Narrative · 0

    RELATED TO (B)(4).

    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) 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. SEE (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224303 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