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

Model Number 8888160341

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported the line was flushed with ns and placed in umbilical vein.Bubbles were noted when pulling back on the syringe and there was leaking at the catheter hub.No air/bubbles reached the patient.The line was immediately removed and a new primed footprint line was placed without difficulty.There was no patient injury.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One physical sample of item code 8888160341 with lot number 2030100064 was received for investigation.The catheter was visually inspected and submitted to underwater testing to identify a possible leak; however, the test did not show any deviations.The sample passed the test, and the reported condition could not be confirmed.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SINGLE LUMEN 5FR
• Type of Device: 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: 16378583
• MDR Text Key: 309567154
• Report Number: 3009211636-2023-00808
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• 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: 2030100064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1