MAUDE Adverse Event Report: CARDINAL HEALTH 5.0FR URETHANE UMB CATH; 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)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the catheter is sharp and hard, it twists and cuts easily causing leaks, the insertion and securing of the line is difficult, and it can only stay in situ for 5days.Per additional information received, the area was cleaned with chlorhexidine and dried prior to insertion.There was no additional information available as the doctor involved declined to answer any further questions.There is no supporting evidence confirming vein perforation occurred.
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Additional Manufacturer Narrative
A device history record (dhr) was not possible as the lot number was reported as unknown.However, all dhr¿s are reviewed per established sampling levels were within acceptable limits during the production process.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample to evaluate, it is not possible to confirm the reported issue or related it to a manufacturing process.As such, the root cause could not be determined based on the available information.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.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 in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.The manufacturing facility will continue to monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.In the case of a repeated issue and/or recurrence, a new investigation for the specific events would be carried out for each case.

• Brand Name: 5.0FR URETHANE UMB CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; edificio b20 calle #2; zona franca coyol; alajuela ; CS
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2; zona franca coyol; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13046838
• Report Number: 3009211636-2021-00772
• Device Sequence Number: 11200198
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 2111100135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/13/2022
• 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