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

Model Number	G55797
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Needle collapsed 3 follicles.
Additional Manufacturer Narrative
The device was not returned for evaluation.Therefore, the visual inspection and functional test could not be performed.No images were provided for evaluation.A review of device history record for work order number (b)(4) was reviewed and appears complete and correct with no evidence that a device non-conformance or deficiency contributed to the reported event.A review of specifications found that a number of processes and checks in place during manufacturing where any blockages would most likely be detected.The subject matter expert medical affairs was consulted on the potential root cause.It was referenced ¿the commonest cause of early collapse/fragility of the follicle is that the follicle is on the point of rupturing spontaneously, in response to the luteinizing hormone [lh] triggering.This can be due to incorrect timing of the trigger, or idiosyncratic individual patient response.Such unusual sensitivity could make the preovulatory follicle unexpectedly fragile, and it could more easily rupture, with consequent loss of the oocyte.A surgeon who is inexperienced could enter follicles with the aspirating pressure not yet turned on.In this situation, a tear of the follicle could allow the fluid to escape before the aspiration starts.That the same problem happened with three follicles does raise the possibility of a hook on the tip of the needle which makes a bigger hole on entry than usual; but if the suction is happening, the oocyte is usually still captured¿.Based on the information provided, a definitive root cause is unknown.Any non-conformance with a device would most likely be detected prior to patient contact during the common clinical practice of a pre-flush with minimal risk to the patient.Please note that an updated 510(k) number has been issued for this device (special 510k 171611).
Event or Problem Description
Needle collapsed 3 follicles.

• Brand Name: OVUM ASPIRATION NEEDLE DOUBLE LUMEN
• Common Device Name: 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 QLD 4 113; AS QLD 4113
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 15136903
• Report Number: 9680654-2022-00012
• Device Sequence Number: 7329820
• Product Code: MQE
• UDI-Device Identifier: 00827002557970
• UDI-Public: (01)00827002557970(17)241223(10)A1092943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2024
• Device Model Number: G55797
• Device Catalogue Number: K-OPSD-1735-A-S-US
• Device Lot Number: A1092943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/31/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female