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

Model Number 8888160531

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the dual lumen 3.5 fr uvs had a hole in below the junction of the bifurcation and was leaking on to the bed.The uvc was removed and had to be replaced.No injury reported.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER DUAL LUMEN 3.5FR
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; 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: 16397241
• MDR Text Key: 309978930
• Report Number: 3009211636-2023-00809
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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: 2202400084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1