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

Model Number 8888160531

Device Problem Break (1069)

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

Event Date 03/27/2024

Event Type  malfunction  

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 Description

Customer reports: the device was found cracked when they opened the product packaging.

• Brand Name: UMBILICAL CATHETER DUAL LUMEN 3.5FR
• Type of Device: 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
• MDR Text Key: 339118265
• Report Number: 3009211636-2024-00808
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 2305800144
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1