OVUM ASPIRATION NEEDLE SINGLE LUMEN
Report
- Report Number
- 9680654-2025-00035
- Event Type
- Injury
- Date Received
- July 5, 2025
- Date of Event
- June 4, 2025
- Report Date
- August 27, 2025
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MQE
- PMA / PMN Number
- K983593
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
RELATED COMPLAINTS: (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(6): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.
ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER AFTER THREE REQUESTS, NO FURTHER INFORMATION WAS RECEIVED. EVALUATION OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED, AS IT WAS DISCARDED AFTER USE. REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER A1164112 FOUND THE WORK ORDER APPEARED COMPLETE AND THE QUALITY CONTROL INSPECTION RECORD WAS VERIFIED TO ENSURE THAT THE DEVICE PASSED INSPECTION. THERE WERE NO NON-CONFORMANCES RAISED AND NO TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. THE RELATED ROOM STOCK ASSEMBLY WORK ORDER FOR THE PRODUCT WAS REVIEWED AND APPEARS COMPLETE AND CORRECT. A TOTAL OF 3 DEVICES WERE REJECTED FOR "MAJOR CONTAMINATION". TWO ADDITIONAL NON-CONFORMANCES WERE RAISED IN THE WORK ORDER WITH A TOTAL OF 3 DEVICES RE-WORKED FOR "FLARE OUT OF SPECIFICATION" AND 7 DEVICES REWORKED FOR "BLUNT END NEEDLE OUT OF SPECIFICATION". THERE IS NOTHING TO INDICATE THAT ANY OF THE NON-CONFORMANCES HAD AN IMPACT ON THE COMPLAINT DEVICE. THERE WERE NO TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. THE ASSOCIATED INSPECTION RECORD CONFIRMS THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. REVIEW OF SPECIFICATIONS FOUND THAT THERE ARE A NUMBER OF CONTROLS AND PROCESSES IN PLACE THAT SHOULD IDENTIFY FAULTY PRODUCT PRIOR TO SHIPPING. A REVIEW OF THE MANUFACTURING RECORDS AND SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THIS IS THE ONLY REPORTED EVENT EVENTS FOR LOT A1164112. THE INFORMATION AVAILABLE FOR THE REPORTED EVENT WAS REVIEWED BY THE MEDICAL ADVISOR, WHO STATED "THERE ARE MANY POSSIBLE CAUSES OF HEMOPERITONEUM, A RECOGNISED COMPLICATION OF USING SHARP NEEDLES IN A VERY VASCULAR OPERATING FIELD. THE UNIT HAS BEEN ASKED IF THESE PATIENTS HAD ANY PREDISPOSING FACTORS FOR INCREASED RISK OF BLEEDING. NO REPLY HAS AS YET BEEN RECEIVED, BUT ONE WOULD NOT EXPECT A SUDDEN SURGE IN CASES TO REPRESENT EXPOSURE TO AN AT-RISK POPULATION DUE TO A CHRONIC CONDITION. THE DEGREE OF EXPERIENCE OF THE OPERATORS OF THE OOCYTE RETRIEVAL IS NOT STATED. POST OPERATIVE HEMOPERITONEUM IS MORE LIKELY WHEN THE OPERATORS ARE INEXPERIENCED. THERE IS A POSSIBILITY THAT THE NEEDLES THEMSELVES COULD BE CONTRIBUTING. EXAMINATION OF THE NEEDLE USED IS ESSENTIAL TO UNDERSTAND IF THE NEEDLES PLAYED ANY ROLE. UNFORTUNATELY, THE HOSPITAL SYSTEMS FOR DEALING WITH SHARPS AND BIOLOGICAL MATERIAL MEANS THE NEEDLES ARE IMMEDIATELY DISCARDED AT THE END OF AN OPERATING SESSION. UNPLANNED UNCONTROLLED BLEEDING WITHIN THE ABDOMEN IS A MEDICALLY FEARED POSTOPERATIVE COMPLICATION. THIS MAY LEAD TO REHOSPITALISATION, BLOOD TRANSFUSION, REPEAT LAPAROSCOPY, EXCISION OF AN OVARY IF THE BLEEDING CANNOT BE CONTROLLED, AND A VERY RARE PATIENT DEATH IS A POSSIBILITY. IN SUMMARY, THERE ARE CLUES IN THE PATTERN OF THESE COMPLAINTS, BUT A CLEAR CAUSE CANNOT BE DEMONSTRATED AT PRESENT. FORTUNATELY, ALL THESE 7 PATIENTS RECOVERED AND DID NOT REQUIRE OVARIAN RESECTION". THE CLINICAL EVALUATION REPORT (CER) FOR OVUM PICK-UP NEEDLES AND SETS ADDRESSES THE FOLLOWING: - 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. - 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. BASED ON THE INFORMATION SUPPLIED, 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 UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA), WHICH WAS INITIATED TO ADDRESS THE INCREASE IN OCCURRENCES OF BLEEDING AFTER USING COOK OVUM PICK-UP NEEDLES. A THOROUGH INVESTIGATION WAS CONDUCTED INTO MANUFACTURING PROCESSES, TEMPORARY DEVIATIONS DURING MANUFACTURE FROM JAN-2019 TO JUN-2022 OF; NEEDLE DESIGN, DESIGN CHANGES ON SINGLE AND DOUBLE LUMEN DEVICES OVER A 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 WAS NO FAULT/NON-CONFORMANCE OF SINGLE AND DOUBLE LUMEN DEVICES, THEIR LABELLING, MANUFACTURING, NOR CLINICAL USE. A NEW CAPA WAS INITIATED ON 23-JUL-2025, TO INVESTIGATE THE TREND IN HEMOPERITONEUM/BLEEDING COMPLAINTS IN COOK OVUM PICK-UP NEEDLES. THIS CAPA IS CURRENTLY UNDER INVESTIGATION. RELATED COMPLAINTS: (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(6): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.
AFTER OOCYTE PICK-UP (7 CASES IN 1 YEAR PERIOD VS 1 CASE/YEAR USUALLY), HAEMOPERITONEUM APPEARS. NONE OF OVUM PICK UP (OPU) NEEDLES WERE KEPT FOR INVESTIGATION. THIS (B)(6): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. RELATED COMPLAINTS: (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(6): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.
AFTER OOCYTE PICK-UP (7 CASES IN 1 YEAR PERIOD VS 1 CASE/YEAR USUALLY), HAEMOPERITONEUM APPEARS. NONE OF OVUM PICK UP (OPU) NEEDLES WERE KEPT FOR INVESTIGATION. THIS (B)(6): CUSTOMER REF NUMBER: (B)(4) MODERATE HAEMOPERITONEUM FOLLOWING FOLLICULAR PUNCTURE. IN-PATIENT MONITORING NOT REQUIRING SURGICAL MANAGEMENT. RELATED COMPLAINTS: (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE FOR IVF COMPLICATED BY HAEMOPERITONEUM REQUIRING LAPAROSCOPIC REVISION IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM ON DAY 1 OF OOCYTE PUNCTURE REQUIRING SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4): FOLLICULAR PUNCTURE COMPLICATED BY A LARGE HAEMOPERITONEUM (1.4L) DUE TO NON-ACTIVE BLEEDING, REQUIRING REVISION IN THE OPERATING THEATRE BY LAPAROSCOPY. (B)(6): CUSTOMER REF NUMBER: (B)(4): HAEMOPERITONEUM 2 DAYS AFTER OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE. (B)(6): CUSTOMER REF NUMBER: (B)(4): OOCYTE PUNCTURE COMPLICATED BY HAEMOPERITONEUM. HOSPITALISATION FOR MONITORING WITHOUT INDICATION FOR SURGICAL MANAGEMENT. (B)(6): CUSTOMER REF NUMBER: (B)(4) HAEMOPERITONEUM FOLLOWING OOCYTE PUNCTURE, REQUIRING REPEAT SURGERY BY LAPAROSCOPY IN THE OPERATING THEATRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2763953 | OVUM ASPIRATION NEEDLE SINGLE LUMEN | MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES¿ | MQE | WILLIAM A. COOK AUSTRALIA, PTY LTD | A1164112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Hospitalization |