MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SNGL LUMEN 3.5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
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 line was leaking from the catheter and blood was backing up.Additional information received on (b)(6) 2024 stated that the skin was cleaned with betadine.The device was secured with tegaderm/suture and each line was flushed with infusing fluids using saline with heparin, and a 3ml syringe.The picc was removed on the same day that it was placed and was subsequently replaced with the same type of catheter.The patient is 6/7 weeks.There was no significant blood loss or signs of distress or complications.The current status of the patient is stable.
Additional Manufacturer Narrative
The device history record (dhr) for each lot affected was reviewed and showed that manufacturing and inspection of the product was performed as per applicable procedures and validated process.One used catheter from product code id 8888160333 was received inside of a generic plastic bag for analysis and investigation.The visual inspection of the sample revealed that the catheter showed signs of use such as residues of blood and a hole was identified in the tube.Additionally, during the physical/ functional evaluation, the sample was submitted to underwater testing and a leak was identified in the tube.Therefore, the condition reported by the customer was confirmed.The reported condition was not confirmed as manufacturing related, therefore no corrective actions are required.According to the visual inspection of the device returned by the customer it can be determined that the hole is a clean cut, as if a sharp object had been used and came into contact with the device.There are no sharp objects used during the manufacturing process therefore it is unclear how the product came into contact with a sharp object.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed at the plant.These processes are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SNGL LUMEN 3.5FR
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19567705
• Report Number: 1423537-2024-00047
• Device Sequence Number: 3981060
• Product Code: FOS
• UDI-Device Identifier: 10884527005116
• UDI-Public: 10884527005116
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/28/2024

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: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2335500094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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