OVUM ASPIRATION NEEDLE SINGLE LUMEN
Report
- Report Number
- 9680654-2025-00037
- Event Type
- Injury
- Date Received
- July 11, 2025
- Report Date
- August 26, 2025
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MQE
- PMA / PMN Number
- K983593
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A TOTAL OF 4 SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM THE SAME FACILITY: (B)(4).
THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AFTER USE. A TOTAL OF 89 UNUSED PRODUCT FROM THE SAME LOT NUMBER: (A1171666) WAS RETURNED FOR EVALUATION AND WILL BE INVESTIGATED UNDER (B)(4) (FDA REFERENCE: 9680654-2025-00045). THE INFORMATION AVAILABLE FOR THE REPORTED EVENT WAS REVIEWED BY THE MEDICAL ADVISOR, WHO STATED THAT THE DESCRIPTION OF EVENTS SUGGESTS THAT IT WAS THE SAME SURGEON INVOLVED IN EACH RELATED CASE, EXCEPT FOR THE SURGEON WHO OPERATED ON THE URGENT CASE WHERE THE OVARY HAD TO BE REMOVED (FDA REFERENCE: 9680654-2025-00037, OUR REFERENCE: (B)(4). THE MEDICAL ADVISOR COMMENTED THAT THE SURGEON DESCRIBED THAT ¿THE REMOVED OVARY SEEMED CUT INTO SLICES¿ WHICH SUGGESTS THAT THE SURGEON WHO PERFORMED THE OVUM PICK UP (OPU) PROCEDURE DID NOT SEE THE TIP OF THE NEEDLE CLEARLY WHICH RESULTED IN SLASHING RATHER THAN PUNCTURING DIRECTLY. THE OPU DOCTOR HAD COMMENTED THAT ¿NOW IN THE SPACE OF A MONTH AND ALWAYS WITH THE SAME BATCH OF NEEDLE ALL THIS HAS HAPPENED, IT SEEMS THAT THE EDGE OF THE TIP IS EXCESSIVELY SHARP AND THEREFORE IN ADDITION TO PRICKING IT CUTS.¿, WHICH THE MEDICAL ADVISOR AT COOK SAYS IS MADE WITH THE VOICE OF EXPERIENCE. THE MEDICAL ADVISOR COMMENTED THAT THIS IS THE FIRST TIME RELATED COMPLAINTS HAVE BEEN RAISED WITHIN A SINGLE LOT NUMBER. THE MEDICAL ADVISOR CONTEMPLATED IF THE ULTRASOUND-VISIBLE MARKS ON THE NEEDLES ALL HAVE THE EXACT SAME PLACEMENT ON THE NEEDLES AND STATED THAT: ¿¿THE CLINICAL WAY IN WHICH A NEEDLE WILL ¿SLICE¿ RATHER THAN PENETRATE IS IF THE NEEDLE INSERTION IS OBLIQUE RATHER THAN AT 90 DEGREES. EVEN A SMALL CHANGE IN THE ULTRASOUND PICTURE OF WHERE EXACTLY THE NEEDLE TIP IS PRESENT CAN RESULT IN MISDIRECTED INSERTIONS.¿ THE MEDICAL ADVISOR BELIEVES THAT IT IS LIKELY TO BE A CLINICAL CULTURE THAT CONTRIBUTED TO THE REPORTED CASES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT THERE HAD NOT BEEN ANY NOTABLE DAMAGE TO THE NEEDLE OR ITS TUBING AT OPENING. FURTHERMORE, IT WAS STATED THAT THE PHYSICIAN HAD ONLY ONCE PREVIOUSLY HAD A PATIENT HOSPITALIZED AFTER THE OPU PROCEDURE AND DISCHARGED TWO DAYS AFTER OBSERVATION. THE PHYSICIAN COMMENTED THAT: ¿IT SEEMS THAT THE EDGE OF THE TIP IS EXCESSIVELY SHARP AND THEREFORE IN ADDITION TO PRICKING IT CUTS. KEEP IN MIND THAT IT IS MY HABIT, WHEN I DO THE PICKUP, I ENTER THE OVARY A MAXIMUM OF TWICE THEN I MOVE INSIDE THE SAME OVARY.¿ IT WAS REPORTED THAT THE ECO MACHINE IS MAINTAINED REGULARLY (ON A YEARLY BASIS) AND THE PHYSICIAN IS THE OWNER OF THE CLINIC. THE PHYSICIAN HAS MORE THAN 15 YEARS OF EXPERIENCE WITH MORE THAN 200 OPU PROCEDURE PER YEAR MAINLY WITH COOK NEEDLES WITH NO PROBLEMS BEFORE THIS COMPLAINT. 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 LOT: A1171666 WAS REVIEWED AND APPEARS COMPLETE AND THE QUALITY CONTROL INSPECTION WAS VERIFIED TO ENSURE THAT THE DEVICE PASSED INSPECTION. THERE WAS ONE NON-CONFORMANCE RAISED AND NO TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. THE NON-CONFORMANCE LEAD TO ONE DEVICE BEING REJECTED. THE ROOM STOCK ASSEMBLY WORK ORDER FOR THE NEEDLES WAS REVIEWED AND APPEARS COMPLETE AND CORRECT. THERE WERE NO ACTIVE TEMPORARY DEVIATIONS IN PLACE OR NON-CONFORMANCE'S RAISED AT TIME OF MANUFACTURE. 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 OF FOUR RELATED EVENTS FOR LOT: A1171666. 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 FROM THE INVESTIGATION. 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. A TOTAL OF 4 SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM THE SAME FACILITY: (B)(4).
IT WAS REPORTED THAT THE TIP OF THE NEEDLE WAS VERY SHARP AND CAUSED ABNORMAL BLEEDING FROM THE ABDOMEN. THE PATIENT HAD FAINTED AT HOME AND WAS HOSPITALIZED WHERE BLOOD WAS FOUND IN THE ABDOMEN. THE PATIENT HAD BLOOD TRANSFUSION AND REMOVAL OF THE RIGHT OVARY.
IT WAS REPORTED THAT THE TIP OF THE NEEDLE WAS VERY SHARP AND CAUSED ABNORMAL BLEEDING FROM THE ABDOMEN. THE PATIENT HAD FAINTED AT HOME AND WAS HOSPITALIZED WHERE BLOOD WAS FOUND IN THE ABDOMEN. THE PATIENT HAD BLOOD TRANSFUSION AND REMOVAL OF THE RIGHT OVARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677368 | OVUM ASPIRATION NEEDLE SINGLE LUMEN | MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES | MQE | WILLIAM A. COOK AUSTRALIA, PTY LTD | A1171666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |