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

Model Number 8888160333

Device Problem Break (1069)

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

Event Date 09/25/2022

Event Type  malfunction  

Event Description

The customer reported they had an argyle umbilical catheter snap.The catheter snapped near the 24cm marking during removal.The catheter was inserted on (b)(6) 2022 and removed on (b)(6) 2022.It was not replaced.There was no harm to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) review could not be performed because a lot number was not available.However, all dhrs are reviewed to meet regulatory requirements prior to product release.One catheter was received for analysis and investigation.The catheter showed signs of use.It was confirmed that the device showed a rupture near the 23cm mark.The reported issue was confirmed.Based on the information received that the catheter snapped during removal, it was determined that the catheter was in working condition during use and was damaged during removal.There are no further actions required for this complaint because the occurrence is below what is expected and the issue was not confirmed as manufacturing related.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) review could not be performed because a lot number was not available.However, all dhrs are reviewed to meet regulatory requirements prior to product release.One catheter was received for analysis and investigation.The catheter showed signs of use.It was confirmed that the device showed a rupture near the 23cm mark.The reported issue was confirmed.Based on the information available its determined that the catheter was in good condition prior use and the exact root cause of the reported issue could not be determined.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Additional information: b4: event description was added to due to information received from the customer.

Event Description

Additional information received february 1, 2023: the customer clarified that the catheter did not break when being removed, it was removed because it broke.

• Brand Name: UMBILICAL CATHETER SNGL LUMEN 3.5FR
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; 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: 15724209
• MDR Text Key: 307117611
• Report Number: 3009211636-2022-00801
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• 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,Followup,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1