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-1733-R-B-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intra-Abdominal Hemorrhage (4479)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) hospital had an issue with 7 patients experiencing bleeding post ovum aspiration with product (from same lot number).All seven patients recovered, a few required stitches, silver nitrate, and extra day in hospital for observations.

• Brand Name: OVUM ASPIRATION NEEDLE SINGLE 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
• MDR Report Key: 17905284
• Report Number: 3005580113-2023-00115
• Device Sequence Number: 7560684
• Product Code: MQE
• UDI-Device Identifier: 00827002552531
• UDI-Public: (01)00827002552531(17)260705(10)A1137762
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2023
• Report Date (Section F): 10/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2026
• Device Catalogue Number: K-OSN-1733-R-B-90
• Device Lot Number: A1137762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/29/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2023
• Date Device Manufactured: 07/05/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 10/10/2023