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

Model Number 8888160333

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

The customer reported that the leaking was identified at the junction between the hub and the tubing when it was used on the patient around 20 minutes.Per additional information received 21jun2022, they switched and stopped using the catheter and they passed the catheter to their sales people for further investigation process.The leaking occurred just below the molded strain relief on the extensions.The catheter was not difficult to handle during insertion.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the device history record (dhr) was reviewed and showed that the lot was manufactured according to standards and that there were no discrepancies that could be related to the event reported.Based on review, it is concluded that the lot was released according to product requirements.One catheter was received for analysis and investigation.According to the visual inspection the catheter did not show signs of use.The physical sample evaluation revealed that the catheter passed the leak test performed.The device did not show bubbles during underwater testing.The reported condition could not be confirmed.There are controls in place at the manufacturing site to detect this type of failure mode such as leak testing and 100% occlusion tests.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 in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• 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: 14851529
• MDR Text Key: 303220265
• Report Number: 3009211636-2022-00791
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1829700083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1