OVUM ASPIRATION NEEDLE SINGLE LUMEN
Report
- Report Number
- 9680654-2025-00025
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- May 19, 2025
- Report Date
- June 8, 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
A TOTAL OF 9 SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM THE SAME FACILITY: (B)(4).
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INFORMATION AVAILABLE FOR THE REPORTED EVENT WAS REVIEWED BY THE MEDICAL ADVISOR, WHO STATED THAT THIS IS A RECOGNIZED COMPLICATION OF THE OOCYTE PICK UP PROCEDURE (OPU). THE EUROPEAN SOCIETY OF HUMAN REPRODUCTION AND ENDOCRINOLOGY HAS DOCUMENTED THIS RATE AS USUALLY BETWEEN 0.06% - 0.2% WITH THE SUGGESTION THAT RATES HAVE BEEN DECLINING SINCE THE MOVE TO GONADOTROPIN-RELEASING HORMONE (GNRH) ANTAGONIST PROTOCOLS AND A HIGHER INCIDENCE OF DELAYED EMBRYO TRANSFERS. THE MEDICAL ADVISOR COMMENTED THAT: ¿THE UNDERLYING PATHOLOGICAL REASON FOR HEMOPERITONEUM OCCURRING IS THAT SWOLLEN HYPER-STIMULATED OVARIES ARE PRONE TO BLEEDING, WITH EASILY CAUSED LACERATIONS; AND INTRODUCED NEEDLES ARE VERY SHARP OBJECTS.¿ THE MEDICAL ADVISOR SAID THAT THE RATE OF HEMOPERITONEUM SEEMED TO BE HIGH AT THE INVOLVED IVF UNIT, BUT THAT IT WAS DIFFICULT TO SAY WHAT THE RATE WAS AS THE TOTAL NUMBER OF OPUS AS A BASELINE TO CALCULATE THE RATE IS NOT KNOWN. THE MEDICAL ADVISOR LISTED THREE MAIN CAUSES OF INCREASED NUMBERS OF HEMOPERITONEUM CASES: ¿THE PATIENT WITH AN ELEVATED RISK FOR BLEEDING; THE NEEDLE ITSELF WITH DEFORMATIONS/MALFORMATIONS THAT INCREASE THE RISK OF TEARING ENTRIES INTO FOLLICLES; OR THE OTHER MAIN FACTOR IN CAUSING BLEEDING, THE SKILLS AND EXPERIENCE OF THE SURGICAL OPERATOR, PARTICULARLY IN THE USE OF TRANSVAGINAL ULTRASOUND (FOR EXAMPLE, AN OBLIQUE ENTRY INTO A FOLLICLE IS MORE LIKELY TO CAUSE TEARING LEADING TO HEAVIER BLEEDING).¿ THE MEDICAL ADVISOR STATED THAT THE LOCALIZATION OF HEMOPERITONEUM CASES TO A CLUMP IN ONE IVF UNIT, WITH ALL EXCEPT TWO CASES USING NEEDLES WITH DIFFERENT LOT NUMBERS INDICATES ¿LOCAL¿ FACTORS RATHER THAN NEEDLE PROBLEMS CAUSING THESE ISSUES. IT WAS ALSO STATED THAT: ¿IF THERE WAS A MANUFACTURING NEEDLE PROBLEM CAUSING THESE CASES, I WOULD EXPECT IT WOULD BE APPARENT WITHIN A PARTICULAR LOT, AND ANY ¿CLUMP¿ OF CASES WOULD APPEAR WHEREVER THAT LOT NUMBER OF COOK NEEDLES IS SOLD.¿ BECAUSE NEEDLES ARE AUTOMATICALLY DISPOSED OF SAFELY INTO A SHARPS CONTAINER IMMEDIATELY AFTER SURGERY, NO NEEDLES INVOLVED HAVE BEEN STUDIED AS YET. THE MEDICAL ADVISOR ALSO COMMENTED THAT: ¿AS A CLINICIAN, I KNOW THAT SEEING A ¿CLUMP¿ OF OPERATIVE COMPLICATIONS IS DEEPLY WORRYING. THE RISK OF LONG-TERM EFFECTS OF HEMOPERITONEUM, SUCH AS FURTHER SURGERY UP TO AND INCLUDING LAPAROTOMY AND BLOOD TRANSFUSION, WOULD MAKE ME APPREHENSIVE WITH EACH SUBSEQUENT OPU. THIS WOULD MAKE ME CAUTIOUS AND EXTRA CAREFUL IN MY OPU CASES, RESULTING IN OPU PROCEDURES TAKING LONGER. IRONICALLY, LONGER DURATION OF OPU¿S HAS BEEN SHOWN TO BE A RISK FACTOR FOR HEMOPERITONEUM AS A COMPLICATION OF OPU. THE LONGER A SHARP NEEDLE IS WITHIN A WOMAN¿S PELVIS, THE HIGHER THE CHANCE IS OF AN UNPLANNED INJURY. THUS, IT IS FEASIBLE THAT ONE FACTOR IN THIS ¿CLUMP¿ IS PROLONGED OPU¿S. I MENTION THIS JUST TO SAY THAT CAUSES OF THESE CASES CAN BE COMPLEX AND MULTIFACTORIAL, AND LOCAL MEDICAL PROTOCOLS, HABITS AND CULTURE CANNOT EASILY BE EXCLUDED AS A FACTOR IN THESE CASES.¿ THE MEDICAL ADVISOR CONCLUDED THAT THE CASE OF HEMOPERITONEUM AT THIS ONE IVF UNIT WAS UNLIKELY TO BE DUE TO A NEEDLE MANUFACTURING ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. IT WAS REPORTED THAT FOLLOWING THE OPU PROCEDURE, THE PATIENT CAME BACK BECAUSE OF ABDOMINAL PAIN AND HEMOPERITONEUM WAS DISCOVERED. THE PATIENT REQUIRED HOSPITAL MONITORING, BUT NO SURGICAL REVISION. IT WAS CONFIRMED THAT THE PATIENT HAD NORMAL STIMULATION OF THE OVARIES. 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 TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. THERE WAS ONE NON-CONFORMANCE RAISED. THE ROOM STOCK ASSEMBLY WORK ORDER FOR THE NEEDLES WAS REVIEWED AND APPEARS COMPLETE AND CORRECT. THERE WERE NO TEMPORARY DEVIATIONS RAISED AT THE TIME OF MANUFACTURE. ONE NON-CONFORMANCE WAS RAISED AT THE TIME OF MANUFACTURE THAT RESULTED IN ONE PRODUCT BEING REJECTED. 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 TWO EVENTS HAVE BEEN REPORTED FOR LOT A1174735. 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. 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 (B)(6) 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 9 SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM THE SAME FACILITY: (B)(4).
THE NEEDLE CREATED HEMOPERITONEUM ON THE PATIENT.
THE NEEDLE CREATED HEMOPERITONEUM ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1522306 | OVUM ASPIRATION NEEDLE SINGLE LUMEN | MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES | MQE | WILLIAM A. COOK AUSTRALIA, PTY LTD | A1174735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |