BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 19789340 · Received July 21, 2024

    Report

    Report Number
    9680654-2024-00065
    Event Type
    Injury
    Date Received
    July 21, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 6, 2024
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    UDI-DI
    00827002304604
    PMA / PMN Number
    K983593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO CUSTOMER CONTACT INFORMATION SUPPLIED.

    Additional Manufacturer Narrative · 0

    NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. NO IMAGING WAS SUPPLIED TO ASSIST THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT DESPITE SEVERAL REQUESTS, NO RESPONSE WAS RECEIVED. A SYMPOSIUM ON THE COMPLICATION OF HEMOPERITONEUM FROM USE OF COOK IVF NEEDLES WAS CONDUCTED AND THE MEDICAL ADVISOR PROVIDED AN OVERVIEW OF WHAT WAS DISCUSSED WITH THE FRENCH CLINICIANS WHO ATTENDED AS FOLLOWS: "THERE IS A STRONG SUGGESTION IN THE SCIENTIFIC LITERATURE THAT SURGICAL EXPERIENCE CORELATES WELL WITH RATE OF HEMOPERITONEUM. ASSOCIATED WITH THAT IS THE RECORDED LENGTH OF THE PROCEDURE. SLOWER PROCEDURES ARE LINKED TO CASES OF HEMOPERITONEUM. ALL IVF NEEDLES ARE VERY SHARP BY DESIGN; BUT THE LONGER A SHARP OBJECT REMAINS INSIDE THE HUMAN PELVIS, THE MORE CHANCE THERE IS FOR A BIGGER BLOOD VESSEL TO BE NICKED OR OPENED". REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND THAT THE WORK ORDER FOR LOT A1152991 APPEARS COMPLETE AND CORRECT. THERE WERE NO NON-CONFORMANCES AT THE TIME OF MANUFACTURING. THE ASSOCIATED INSPECTION RECORD CONFIRMS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. REVIEW OF SPECIFICATIONS FOUND THAT THERE ARE A NUMBER OF CONTROLS AND PROCESSES IN PLACE THAT WOULD IDENTIFY FAULTY PRODUCT PRIOR TO SHIPPING. THE MANUFACTURER¿S CLINICAL EVALUATION REPORT FOR OVUM PICK-UP NEEDLES AND SETS ADDRESSES THE FOLLOWING: - HEMORRHAGE/BLEEDING IS WELL-KNOWN AND DESCRIBED IN THE LITERATURE AS A POSSIBLE ADVERSE EVENT OCCURRING FROM THE USE OF ANY OVUM PICK-UP NEEDLE DURING THE OOCYTE COLLECTION PROCEDURE. - IN CONCLUSION, THE COOK OVUM PICK-UP NEEDLES AND SETS ARE CONSIDERED TO BE SAFE AND EFFECTIVE AND TO BE IN ACCORDANCE WITH THE STATE-OF-THE-ART FOR THEIR INTENDED USE. A REVIEW OF THE RELEVANT RECORDS DETERMINED THAT THIS IS A REPEAT INCIDENT OF THIS FAILURE FOR THIS MANUFACTURING LOT A1152991. THE SECOND COMPLAINT ((B)(4)) FOR THIS LOT NUMBER WAS REPORTED BY THE SAME CUSTOMER 13 DAYS APART. A REVIEW OF THE MANUFACTURING RECORDS AND SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE ARE A NUMBER OF PROCESSES AND CHECKS IN PLACE WHERE A BLUNT OR DAMAGED NEEDLE WOULD MOST LIKELY BE DETECTED PRIOR TO SHIPMENT. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE POTENTIAL ROOT CAUSES ARE: - PATIENT RELATED FACTORS. - PROCEDURAL COMPLICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED AT ANY TIME IN THE FUTURE, THE NEW INFORMATION WILL BE REVIEWED TO DETERMINE IF IT IMPACTS THE INVESTIGATION, AND AN ADDITIONAL REPORT MAY BE SUBMITTED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. THE APPROPRIATE PERSONNEL WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NOTE: (B)(4) ARE RELATED - ALL EVENTS FROM THE SAME FACILITY; AND OCCURRED WITHIN A FEW WEEKS OF EACH OTHER.

    Description of Event or Problem · 0

    HEMOPERITONEUM AFTER OPU PROCEDURE. THEY USED OUR PUMP K-MAR-5200 COOK NEEDLES (K-DVLF-240/K-OSN- AND COOK TEST TUBE HEATER K-FTH-1012.

    Description of Event or Problem · 0

    HEMOPERITONEUM AFTER OPU PROCEDURE. THEY USED THE COOK PUMP K-MAR-5200 COOK NEEDLES K-DVLF-240/K-OSN- AND COOK TEST TUBE HEATER K-FTH-1012. THE DEPRESSION USED IS -112/115 MMHG - THE PUNCTURE WAS CARRIED OUT BY A JUNIOR DOCTOR. UNDER GENERAL ANESTHESIA . THE OOCYTE PUNCTURE LASTED 10 MINUTES. THE BLEEDING WAS OBSERVED 6 HOURS AFTER THE PUNCTURE - A TOTAL AMOUNT OF BLOOD : 400 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025578 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD A1152991 00827002304604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female