BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 24372652 · Received February 17, 2026

    Report

    Report Number
    9680654-2026-00038
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    July 1, 2025
    Report Date
    February 17, 2026
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    PMA / PMN Number
    K983593
    Removal / Correction Number
    CAPA-00290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR EVALUATION. TO FACILITATE A THOROUGH INVESTIGATION, ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER. DESPITE THREE FOLLOW-UP ATTEMPTS, NO ADDITIONAL INFORMATION WAS PROVIDED. THE MEDICAL ADVISOR WAS CONSULTED TO ASSESS THE INFORMATION RECEIVED FROM THE CUSTOMER VIA ANSM. THE MEDICAL ADVISOR NOTED THAT THE PATIENT SUFFERED A HYPOTENSIVE EMERGENCY WITHIN TWO HOURS OF THE OVUM PICK UP (OPU) PROCEDURE. THE MEDICAL ADVISOR STATED THAT: ¿SUBSEQUENT ULTRASOUND SHOWED A FLUID COLLECTION IN THE SPACE BETWEEN THE UTERUS AND THE BLADDER WHICH WAS NOT SEEN ON AN EARLIER SCAN. THIS SITUATION EVOLVED INTO A CLASSIC PRESENTATION OF UNCONTROLLED INTRAPERITONEAL BLEEDING. AT SOME POINT IN THE OPU PROCEDURE, A SIGNIFICANT BLOOD VESSEL WAS TORN/OPENED UP BY SOMETHING SHARP. FREE BLEEDING OCCURRED SUBSEQUENTLY, LEADING TO THE EMERGENCY. THE ONLY INTRAPELVIC INSTRUMENT IS THE OPU NEEDLE.¿ THE MEDICAL ADVISOR COMMENTED THAT BLEEDING INTO THE ABDOMINAL CAVITY CAUSES A CLEAR ULTRASOUND OUTLINE OF ANY STRUCTURES WITHIN THE CAVITY. IN SUCH CASES IT IS COMMON FOR BLOOD TO FLOW OR TRACK UPWARDS FREELY INTO THE PERI HEPATIC SPACE, BETWEEN THE LIVER CAPSULE AND THE DIAPHRAGM. SOMETIMES THAT FLOW MAY BE IMPEDED BY ADHESIONS, WHICH FOR EXAMPLE COULD BE BETWEEN THE LIVER AND THE DIAPHRAGM. ADHESIONS USUALLY DEVELOP FROM AN AREA OF INFLAMMATION OF THE PERITONEUM. THE MEDICAL ADVISOR STATED THAT: ¿IT IS POSSIBLE THAT PARTS OF THE BLOOD COULD ENTER LOCULATIONS CAUSED BY THOSE ADHESIONS. THOSE ADHESIONS COULD ¿OBSTRUCT¿ THE BLOOD FROM FLOWING FURTHER, THUS CAUSING A ¿PERIHEPATIC OBSTRUCTION¿, OR INDEED ¿PERIHEPATIC LAMINA¿ OR LAYERING.¿ THE MEDICAL ADVISOR NOTED THAT SIGNIFICANT ENDOMETRIOSIS IS A WELL RECOGNIZED RISK FACTOR FOR A DIFFICULT OPU PROCEDURE AND IS ASSOCIATED WITH AN INCREASED INCIDENCE OF POST-OPERATIVE HAEMOPERITONEUM. THE INFLAMMATORY CONDITIONS CAUSED BY ENDOMETRIOSIS COULD CAUSE SCARRING AND ADHESIONS WHICH MUST HAVE BEEN A FACTOR IN THE REPORTED EVENT. THE MEDICAL ADVISOR EMPHASISED THAT THE OPU NEEDLE IS THE ONLY SHARP OBJECT WITHIN THE PELVIS. A REVIEW OF THE MANUFACTURING RECORDS AND COMPLAINT HISTORY COULD NOT BE COMPLETED AS THE LOT NUMBERS ARE UNKNOWN. A REVIEW OF THE SPECIFICATIONS FOR OVUM ASPIRATION NEEDLES FOUND THAT THERE ARE A NUMBER OF CONTROLS AND PROCESSES IN PLACE 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. 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. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE POTENTIAL ROOT CAUSES ARE: PATIENT RELATED FACTORS, PROCEDURAL COMPLICATIONS. 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 3 YEAR PERIOD, 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 PENDING IMPLEMENTATION. WE APOLOGIZE FOR THE DELAY IN SUBMITTING THIS REPORT. AS THE REQUIRED TIMELINE FOR SUBMITTING AN INITIAL REPORT WAS NOT MET, THE MANUFACTURER HAS INITIATED AN INTERNAL NON-CONFORMANCE INVESTIGATION TO ADDRESS THE FAILING. SHOULD ADDITIONAL INFORMATION FOR ANY OF THE THREE REPORTED EVENTS BE RECEIVED AT ANY TIME IN THE FUTURE THE INVESTIGATION WILL BE UPDATED, AND AN ADDITIONAL REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORTS OF A TOTAL OF 3 PATIENTS EXPERIENCING HAEMOPERITONEUM. DEEP HAEMORRHAGE REPORTED AFTER USING UNKNOWN OVUM ASPIRATION NEEDLES AS REPORTED BY THE CUSTOMER TO ANSM AND "2 REAL CASES ALMOST NEAR THE DEATH" REPORTED BY THE CUSTOMER TO THE SALES REP (NO FURTHER DETAILS SUPPLIED). ONE CASE OF DEEP HAEMORRHAGE REPORTED DIRECTLY TO THE FRENCH REGULATORY AUTHORITY (ANSM) BY END USER CUSTOMER (AS AN EVENT RELATED TO THE USE OF THE VACUUM PUMP (K-MAR-5200). "ON (B)(6) 2025: A 30-YEAR-OLD WOMAN WAS ADMITTED TO THE ASSISTED REPRODUCTIVE TECHNOLOGY (ART) DEPARTMENT FOR EGG RETRIEVAL AS PART OF FERTILITY PRESERVATION DUE TO ENDOMETRIOSIS. THERE WAS NO FLUID COLLECTION IMMEDIATELY AFTER THE RETRIEVAL. AT 1:00 PM, FOLLOWING AN INITIAL VASOVAGAL EPISODE, THE PATIENT PRESENTED WITH A 4 CM FLUID COLLECTION IN THE VESICOUTERINE SPACE, DIAGNOSED BY ULTRASOUND (BP 90/60 MMHG, HR 65 BPM). HER ABDOMEN WAS TENDER, BUT SHE REPORTED MINIMAL PAIN. THE PHYSICIAN REQUESTED AN EXTENSION OF MONITORING FOR ONE HOUR AND AN ULTRASOUND AT A LATER DATE. AT 1:45 PM, THE MIDWIVES ALERTED THE PHYSICIAN FOLLOWING A SECOND EPISODE, A DROP IN BP (80/50 MMHG), AND AN HR OF 70 BPM. A 1L RINGER'S SOLUTION WAS PRESCRIBED VIA IV CATHETER, AND AN URGENT COMPLETE BLOOD COUNT (CBC) WITH ANTIBODY SCREENING WAS ORDERED. THE PATIENT WAS EXPERIENCING PAIN AND ABDOMINAL TENDERNESS. AT 1:55 PM, BLOOD PRESSURE DROPPED TO 69/45 MMHG. THE ON-CALL PHYSICIAN AND ANESTHESIOLOGIST WERE CALLED, FOLLOWED BY THE SURGEON. AT 2:00 PM, A SECOND IV LINE WAS INSERTED AND RINGER'S TEST WAS PERFORMED (BP 80/50 MMHG, HR 70 BPM). AN ULTRASOUND REVEALED SIGNIFICANT BLOOD CLOTS AND A PERIHEPATIC EFFUSION. AN EMERGENCY LAPAROSCOPY WAS PERFORMED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AT 2:10 PM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426424 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female