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-B-90

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

There were 2 similar incidents reproted for the same customer: (b)(4): 05/12 lot number a 1137999 a hemoperitoneum was discovered and the patient had to go to surgery.(b)(4): 07/12 lot number a 1137999 a hemoperitoneum was discovered and the patient had to go to surgery.

Event Description

There were 2 incidents: this (b)(4): 05/12 lot number a 1137999 a hemoperitoneum was discovered and the patient had to go to surgery.See (b)(4) for: 07/12 lot number a 1137999 a hemoperitoneum was discovered and the patient had to go to surgery.

Event Description

There were 2 incidents: this (b)(4): 05/12, lot number: a 1137999 a hemoperitoneum was discovered and the patient had to go to surgery.See (b)(4) for: 07/12, lot number: a 1137999 a hemoperitoneum was discovered and the patient had to go to surgery.

Manufacturer Narrative

The device was not returned for evaluation, and no images were supplied to assist the investigation.Additional information was requested - however, after several requests no additional information was provided.Review of device history record found that the work order: (b)(4) appears complete and correct.There were no active temporary deviations during the processing of this work order.The associated inspection record indicates that the device was manufactured to specification.Review of specifications found that there are a number of controls and processes in place where 100% of the needles are tested to ensure the quality is not affected.At various steps in the respective specifications at different stages of manufacture, a blunt needle would likely have identified.Clinical evaluation report for ovum pick-up needles and sets 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 an extensive investigation into manufacturing processes, temporary deviations during manufacture from jan-2019 to jun-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, 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 information, a definitive root cause could not be determined.The potential root causes are: patient related factors, procedural complications.

• 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: 18323727
• MDR Text Key: 330428764
• Report Number: 9680654-2023-00144
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 00827002296268
• UDI-Public: (01)00827002296268(17)260705(10)A1137999
• Combination Product (y/n): N
• PMA/PMN Number: K983593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OSN-1735-B-90
• Device Lot Number: A1137999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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): Required Intervention
• Patient Sex: Female