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

Model Number	8888160556
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the device will not be returned for evaluation because it has been discarded.
Event or Problem Description
Customer reports: the device was found cracked when they opened the product packaging.
Additional Manufacturer Narrative
According to the sales rep, it has been confirmed that the incorrect product code was initially reported.Based on the new information received on 05/15/24, the following fields have been updated: d1: brand name - updated from umbilical catheter dual lumen 3.5fr to umbilical catheter dual lumen 5fr.D4: model number - updated from product code # 8888160531 to product code # 8888160556.D4: unique identifier (udi) # updated from (b)(4).
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event, and determined that: 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.Two catheter samples with no signs of use were received in a generic plastic bag within their original package with the intact seal.Visually, there were no issues detected.Additionally, a leak test was performed under water to evaluate the reported defect and the test performed showed that the catheter did not leak.Based on the investigation, it was not possible to determine the root cause of the event.A100% in process visual inspection is performed at the plant to prevent nonconforming product from leaving the manufacturing operations.All information received will be used for further tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER DUAL 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 02048 ; 5086183640
• MDR Report Key: 19003714
• Report Number: 3009211636-2024-00808
• Device Sequence Number: 8446184
• Product Code: FOS
• UDI-Device Identifier: 10884527005185
• UDI-Public: 10884527005185
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 07/22/2024

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: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 2305800144
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/16/2024; 07/22/2024
• 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