MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD OVUM ASPIRATION NEEDLE SINGLE LUMEN; MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES

Catalog Number K-OSN-1735-R-B-90

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/12/2023

Event Type  Injury  

Event Description

Too much bleeding so that patients ended up going to er after egg retrieval.It happened to two patients in a row on (b)(6) 2023.(b)(6) patient 1 & (b)(6) patient 2) the patients reported to the er with pelvic pain, drop in hematocrit and required pain management.No transfusion was required.The same physician performed both egg retrieval procedures.No more than minimal bleeding was noted immediately after each surgery was performed.No abnormality or damage to the needles was identified on opening, during or after use.

Manufacturer Narrative

(b)(6) and (b)(6) are related (one for each patient).The complaint device is not available for evaluation.7 unused devices will be supplied for evaluation under (b)(6).

Manufacturer Narrative

No part of the device was returned for evaluation.No imaging was received to assist the investigation.Additional information was requested, but no response was received.Review of device history record (dhr) found the work order for lot a1129136 appeared complete, and the quality control inspection was verified to ensure that the devices passed inspection.There is no evidence that a device non-conformance or deficiency contributed to the reported event.One device was rejected due to damaged tip (dislodged protector).Thirteen devices were rejected due to ¿dust and debris¿.There were no temporary deviations in place at the time of manufacture.Review of specifications found that there are a number of processes and checks in place which would identify a damaged needle prior to shipment.The instructions for use (ifu) supplied with k-osn devices in the usa for general information states: "precautions: vaginal bleeding has been reported to be associated with the transvaginal route for oocyte retrieval via needle aspiration.Bleeding is typically easily controlled with direct pressure." an earlier heath risk assessment (hra) was raised to address the concerns of increasing reports of bleeding post procedure in 2021/2022.Hemoperitoneum is a recognized complication related to the use of needles to aspirate follicles for oocytes in ivf.These incidents related to single lumen ovum pick-up needles and double lumen ovum pick-up needles.A root cause for the trend was not able to be determined.To date, complaint investigations have not identified a manufacturing or design defect.The devices meet their defined quality specifications.Engineering risk management of the design and process risks found that from an engineering perspective, the failure modes which can contribute to ¿bleeding¿ are controlled by design and process risk mitigations.There is no evidence to indicate the failure modes which cause bleeding had occurred, and there are suitable controls in place to reduce the risks of these failures occurring as much as possible.Clinical evaluation report for ovum pick-up needles addresses the following: - hemorrhage/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.An earlier corrective and preventative action (capa) was initiated to address an increase of bleeding after using cook ovum pick-up needles.After extensive investigation into manufacturing processes, needle design, design changes on single and double lumen devices over the proceeding 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, a single root cause could not be identified.The manufacturer has a quality management system (qms) requirement to always review the complaint history during a complaint investigation to ensure that trends are constantly monitored.Based on the available information a definitive root cause could not be determined.The potential root causes are: - insufficiently trained physician.- patient related factors.- procedural complications.Should additional information be received at any time in the future the investigation may be updated, and an additional report may be supplied.

Event Description

Too much bleeding so that patients ended up going to er after egg retrieval.It happened to two patients in a row on wednesday (b)(6) 2023.((b)(4) patient 1 & (b)(4) patient 2) the patients reported to the er with pelvic pain, drop in hematocrit and required pain management.No transfusion was required.The same physician performed both egg retrieval procedures.No more than minimal bleeding was noted immediately after each surgery was performed.No abnormality or damage to the needles was identified on opening, during or after use.

• Brand Name: OVUM ASPIRATION NEEDLE SINGLE LUMEN
• Type of Device: MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 17386057
• MDR Text Key: 319668896
• Report Number: 9680654-2023-00080
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 00827002554771
• UDI-Public: (01)00827002554771(17)260228(10)A1129136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OSN-1735-R-B-90
• Device Lot Number: A1129136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female