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

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

Patient Problem Intra-Abdominal Hemorrhage (4479)

Event Type  Injury  

Event 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
• 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
• MDR Report Key: 17905284
• MDR Text Key: 325293864
• Report Number: 3005580113-2023-00115
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 00827002552531
• UDI-Public: (01)00827002552531(17)260705(10)A1137762
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 10/10/2023
• Distributor Facility Aware Date: 09/29/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2023
• 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): Other
• Patient Sex: Female