BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 22476631 · Received July 11, 2025

    Report

    Report Number
    9680654-2025-00040
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    July 1, 2025
    Report Date
    October 13, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS REPORTED EVENT IS FROM THE SAME CUSTOMER/FACILITY, WHO HAS REPORTED THE FOLLOWING EVENTS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INFORMATION AVAILABLE FOR THE REPORTED EVENT WAS REVIEWED BY THE MEDICAL ADVISOR, WHO COMMENTED THAT THIS WAS REPORTED BY THE SAME CLINIC WHO REPORTED COMPLAINTS (B)(4) AND THAT WITHOUT A RETURNED NEEDLE, THE CAUSALITY MAY REMAIN UNCLEAR. THE MEDICAL ADVISOR STATED THAT THE POSSIBLE CONTRIBUTING FACTORS THAT CAN LEAD TO POST OOCYTE PICK UP PROCEDURE (OPU) HEMOPERITONEUM CAN BE GROUPED AS FOLLOWS: - PATIENT: BLEEDING DISORDER, GNRH-AGONIST STIMULATION PROTOCOL, YOUNGER PATIENT, LOW BMI - OPERATOR: JUNIOR SURGEON ¿ PERFORMED LESS THAN 250 OPU¿S, TRANSVAGINAL ULTRASOUND INEXPERIENCE, ULTRASOUND MACHINE NEEDS CALIBRATION, POOR VISUALIZATION OF NEEDLE TIP; ADVANCING NEEDLE WHEN TIP NOT CLEARLY VISIBLE, TYPE OF ANESTHESIA, THEATRE STAFF EXPERTISE - EQUIPMENT: USE OF SYRINGE TO ASPIRATE FOLLICLES, RATHER THAN A VACUUM PUMP DESIGNED FOR OPU¿S, WHEN THE NEEDLE USED IS NOT DESIGNED TO ATTACH TO THE SYRINGE, POTENTIALLY LEADING TO UNCONTROLLED MOVEMENTS BY THE OPERATOR. - NEEDLE: MANUFACTURING ISSUES. THE MEDICAL ADVISOR STATED THAT: ¿WITHOUT EXAMINATION OF THE NEEDLE, NO COMMENT CAN BE MADE CONCERNING THIS EPISODE. IF THE NEEDLE WAS AVAILABLE, IT WOULD BE IMPORTANT TO CHECK THE TIP OF THE NEEDLE IS NOT BURRED OR HOOKED, AND THAT THE ECHO-TIPPING IS NORMALLY PLACED; AND THAT THERE WAS NO BEND IN THE NEEDLE. DAMAGE IN TRANSIT TO THE IVF UNIT, OR WITHIN THE IVF UNIT STORAGE SYSTEM.¿ ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE HAD BEEN NO NOTABLE DAMAGE TO THE NEEDLE OR ITS TUBING AT OPENING. WHEN HEMOPERITONEUM WAS DISCOVERED, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO STOP THE BLEEDING. THERE WERE NOT ANY NOTABLE ENVIRONMENTAL OR BIOLOGICAL FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE AS FAR AS THEY ARE AWARE. THE CLINICAL EVALUATION REPORT (CER) FOR OVUM PICK-UP NEEDLES ADDRESSES THAT HAEMORRHAGE/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. THE CER CONCLUDES THAT 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. THE DEVICE HISTORY RECORD FOR WORK ORDER FOR (B)(4) WAS REVIEWED AND APPEARS COMPLETE AND THE QUALITY CONTROL INSPECTION WAS VERIFIED TO ENSURE THAT THE DEVICE PASSED INSPECTION. THERE WERE NO NON-CONFORMANCES RAISED OR TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. THE ROOM STOCK ASSEMBLY WORK ORDER FOR THE NEEDLES WAS REVIEWED AND APPEARS COMPLETE AND CORRECT. THERE WERE NO ACTIVE TEMPORARY DEVIATIONS IN PLACE AT TIME OF MANUFACTURE OR NON-CONFORMANCES RAISED. THE ASSOCIATED INSPECTION RECORD CONFIRMS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION PRIOR TO SHIPMENT FROM THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS AND SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THIS IS THE FIRST REPORTED EVENT FOR LOT A1159410. THERE ARE A NUMBER OF PROCESSES AND CHECKS IN PLACE AT WILLIAM A. COOK AUSTRALIA, PTY. LTD. WHICH WOULD IDENTIFY A BLUNT OR DAMAGED NEEDLE PRIOR TO SHIPMENT. THESE INCLUDE: - PACKING SHALL BE ACCOMPLISHED IN SUCH A MANNER AS TO ENSURE THAT THE PRODUCT, DURING SHIPMENT AND STORAGE, WILL NOT BE PERMANENTLY DISTORTED AND WILL BE PROTECTED AGAINST DAMAGE FROM EXPOSURE TO WEATHER OR ANY NORMAL HAZARD. TWISTED KINKS SHALL NOT BE ACCEPTABLE. - THE OUTER SURFACE AND INNER LUMEN CLEAN, SMOOTH, BRIGHT AND FREE FROM DEFECTS, FREE FROM FOREIGN MATTER, SCALE AND KINKS. - CHECK NEEDLE BEVELS FOR BURRS, SHARPNESS, DAMAGE AND ECHO TIP POSITIONING. - VISUALLY CHECK THE CANNULA SURFACE FOR DAMAGE OR MARKS. BASED ON THE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE POTENTIAL ROOT CAUSES ARE: - PATIENT RELATED FACTORS - PROCEDURAL COMPLICATIONS - NEEDLE MANUFACTURING ISSUES THE ISSUE OF HEMOPERITONEUM HAS BEEN PREVIOUSLY INVESTIGATED IN CAPA PR339773, WHICH WAS INITIATED TO ADDRESS THE INCREASE IN CASES OF BLEEDING AFTER USING COOK OVUM PICK-UP NEEDLES. A THOROUGH INVESTIGATION WAS CONDUCTED INTO MANUFACTURING PROCESSES, TEMPORARY DEVIATIONS DURING MANUFACTURE BETWEEN JANUARY 2019 TO JUNE 2022, NEEDLE DESIGN, DESIGN CHANGES ON SINGLE AND DOUBLE LUMEN DEVICES OVER THE LAST 3 YEARS, ASSESSMENT OF CLINICAL FACTORS, AND EVALUATION OF RETURNED COMPLAINT PRODUCTS BOTH IN-HOUSE AND BY PUNCTURE STRENGTH, PUNCTURE DURABILITY AND DRAG FORCE TEST. THE CONCLUSION OF THE INVESTIGATION WAS THAT THERE IS NO FAULT/NON-CONFORMANCE OF SINGLE AND DOUBLE LUMEN DEVICES, THEIR LABELLING, IFU, MANUFACTURING, NOR CLINICAL USE. CAPA-00290 WAS INITIATED ON 23RD OF JULY 2025, TO INVESTIGATE THE INCREASE IN REPORTED CASES OF HEMOPERITONEUM/BLEEDING COMPLAINTS IN COOK OVUM PICK-UP NEEDLES. THIS CAPA IS CURRENTLY UNDER INVESTIGATION. PLEASE NOTE THAT THIS REPORTED EVENT IS FROM THE SAME CUSTOMER/FACILITY, WHO HAS REPORTED THE FOLLOWING EVENTS: (B)(4).

    Description of Event or Problem · 0

    THE NEEDLE CREATED HEMOPERITONEUM ON THE PATIENT WHICH REQUIRED SURGICAL REVISION.

    Description of Event or Problem · 0

    THE NEEDLE CREATED HEMOPERITONEUM ON THE PATIENT WHICH REQUIRED SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072901 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD A1159410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female