BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 22407007 · Received July 5, 2025

    Report

    Report Number
    9680654-2025-00034
    Event Type
    Injury
    Date Received
    July 5, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 27, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED COMPLAINTS: (B)(6): CUSTOMER REF NUMBER: MV25-74: OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(6): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.

    Description of Event or Problem · 0

    AFTER OOCYTE PICK-UP (7 CASES IN 1 YEAR PERIOD VS 1 CASE/YEAR USUALLY), HAEMOPERITONEUM APPEARS. NONE OF OVUM PICK UP (OPU) NEEDLES WERE KEPT FOR INVESTIGATION. THIS (B)(4): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. RELATED COMPLAINTS: (B)(4): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(4): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(4): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(4): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(4): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. (B)(4): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.

    Description of Event or Problem · 0

    AFTER OOCYTE PICK-UP (7 CASES IN 1 YEAR PERIOD VS 1 CASE/YEAR USUALLY), HAEMOPERITONEUM APPEARS. NONE OF OVUM PICK UP (OPU) NEEDLES WERE KEPT FOR INVESTIGATION. THIS (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. RELATED COMPLAINTS: (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(6): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763950 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD A1180355

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention| H