MAUDE Adverse Event Report: CARDINAL HEALTH LLC CARDINAL HEALTH; TUBING, NONINVASIVE

Model Number	N56A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Event or Problem Description
Customer reports: the cardinal health non-conductive suction tubing clogs a lot when patients are being suctioned, and they tend to collapse.I do not have the lot number for the product and am awaiting additional information from the customer.I do not know if there was an impact to a patient.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because the lot number was not provided.No physical sample was returned for evaluation.In accordance with established procedures, all finished products undergo functional inspection and ¿tubing collapse¿ testing prior to release.Based on the available information, a definitive root cause could not be identified and as such a corrective action taken.Monitoring and trending for the reported issue will continue fy2026.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): CARDINAL HEALTH LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23882026
• Report Number: 1423537-2025-00513
• Device Sequence Number: 4706469
• Product Code: GAZ
• UDI-Device Identifier: 10885380072291
• UDI-Public: 10885380072291
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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
• Device Model Number: N56A
• Device Catalogue Number: N56A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown