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

Catalog Number	K-OPSD-1635-A-S-US
Medical Device Problem Codes	Material Disintegration (1177); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After an ivf retrieval, a piece of plastic was seen as the lab was looking through the fluid under microscope.The needle has already been put in the sharps box so there is no way of knowing which one we used today.The lot # a1153708 and it was the ovum aspiration needle double lumen ref (b)(4).
Additional Manufacturer Narrative
Photographic evidence was returned for evaluation.The medical images provided were reviewed by the medical director; it was concluded that the imaging identifies a foreign body, consistent with having been manufactured and is most likely plastic.Review of device history records found that the work order for lot a1153708 appears complete and correct.There were no temporary deviations, and a total of 5 non-conformances documented at the time of manufacturing.All non-conforming product was rejected and therefore do not impact this complaint.The associated inspection records confirm that the device was manufactured to specification.A review of the relevant manufacturing records confirms that this is the first complaint received for lot a1153708.Review of specifications found that there are a number of processes and checks in place at the manufacturing site which would be likely to identify any foreign material in the packaging prior to shipment.During consultation with a subject matter expert and considering the medical director's assessment, it was concluded that it is most likely that manufacturing factors (operator error ¿needle protector scraped by needle tip¿) and/or procedural factors contributed to this event.The relevant manufacturing team was notified about this occurrence, and retraining was conducted to the operators involved on processing this device.Trending will monitor if any future actions are required.After considering this event the risk associated with the use of this device is still deemed adequate.
Event or Problem Description
After an ivf retrieval, a piece of plastic was seen as the lab was looking through the fluid under microscope.The needle has already been put in the sharps box so there is no way of knowing which one we used today.The lot # a1153708 and it was the ovum aspiration needle double lumen ref (b)(4).

• 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 ; 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: 20061135
• Report Number: 9680654-2024-00069
• Device Sequence Number: 12708796
• Product Code: MQE
• UDI-Device Identifier: 00827002557888
• UDI-Public: (01)00827002557888(17)270228(10)A1153708
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: K-OPSD-1635-A-S-US
• Device Lot Number: A1153708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/25/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown