MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SNGL LUMEN 2.5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160325
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the sr.Was attempting to flush the catheter, but the catheter seemed to be blocked.They were unable to use said catheter.The catheter was not inserted, they found the blockage before it was inserted.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The actual sample involved in the reported incident was not returned for evaluation nor were any photos or videos received.Consequently, it was not possible to evaluate a sample as part of a comprehensive failure investigation.However, it is important to note that corrective and preventative actions were implemented after the manufacture of the reported lot to address the reported condition.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
One used catheter was received for the investigation.The sample was inspected, and the reported condition was confirmed; a material was found inside the tip of the catheter obstructing the flow path.Further testing showed that the occlusion is not a foreign particle, it¿s part of the tube material.A definitive root cause could not be determined at this time.However, actions have been implemented to address the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SNGL LUMEN 2.5FR
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15678759
• Report Number: 3009211636-2022-00800
• Device Sequence Number: 7941136
• Product Code: FOS
• UDI-Device Identifier: 20884527005106
• UDI-Public: 20884527005106
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2024

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: 8888160325
• Device Catalogue Number: 8888160325
• Device Lot Number: 1913500240
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 10/26/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/16/2022; 03/01/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown