MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SINGLE LUMEN 5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the product is leaking.
Additional Manufacturer Narrative
The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One product sample was provided by the customer.The sample showed signs of use such as a tape in the tube and adapters at both ends of adapters of the catheter.Per visual inspection no issues were detected.Also, a leak test was conducted to evaluate the reported issue.The test showed that the catheter did not present any leaks.Therefore, the reported condition could not be confirmed.This complaint will be used for tracking and trending purposes.All information received will be used for further tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SINGLE LUMEN 5FR
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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 ; 5086183640
• MDR Report Key: 18938200
• Report Number: 3009211636-2024-00803
• Device Sequence Number: 6886311
• Product Code: FOS
• UDI-Device Identifier: 10884527005123
• UDI-Public: 10884527005123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 2303100243
• 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: 03/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown