MAUDE Adverse Event Report: CARDINAL HEALTH FLEX ADVANTAGE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-920C
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a "close call" with a baby.The suction wasn't working.The staff confirmed checking that the suction was working when it was setup, but when they went to use it, it was not working.When they got it to work, it was too powerful.Manual maneuvers used to remove mucus plug from neonate.Delay was several seconds.Customer reported no adverse effect to the patient.
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Two physical samples were provided for review and investigation.A laboratory test performed showed both test samples passing regular and low intermittent vacuum testing with no drop in vacuum (in.Hg).Root cause for the reported concern cannot be identified with the amount of information available.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: FLEX ADVANTAGE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21438198
• Report Number: 1423537-2025-00095
• Device Sequence Number: 4528224
• Product Code: GCX
• UDI-Device Identifier: 50885380029088
• UDI-Public: (01)50885380029088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 65651-920C
• Device Catalogue Number: 65651-920C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown