MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CESAREAN SECTION TRAY

Model Number	SMA13CCEMZ
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: c/s pack bulb syringes for infant suctioning at delivery-is bent and does not work-both in pack.3rd c/s noted this week where bulb syringes provided nonfunctional and not able to detect until time of use.Further inspection shows stem slightly bent that prevents adequate use.3rd bulb syringe packaged separately opened and used and adequately works-compared 2 after delivery and discrepancy noted.

• Brand Name: CARDINAL HEALTH
• Common Device Name: CESAREAN SECTION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 21881306
• Report Number: 21881306
• Device Sequence Number: 7766183
• Product Code: OHM
• UDI-Device Identifier: 10197106788530
• UDI-Public: (01)10197106788530
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2025
• Report Date (Section F): 04/17/2025

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 Model Number: SMA13CCEMZ
• Device Catalogue Number: SMA13CCEMZ
• Device Lot Number: 458733
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• 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: Male
• Patient Weight: 3 KG
• Date Report Sent to FDA: 04/17/2025