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

Model Number 8888160531

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the lines had air when aspirating both in veins and arteries with solution coming out of one side.There was no patient harm.

Manufacturer Narrative

The device history record (dhr) was reviewed, and it revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The device was manufactured on april 19, 2021.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.According to the investigation performed, the manufacturing process and controls were analyzed, and no manufacturing or design issues were identified.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.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR DUAL-LUMEN UVC CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• 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: 13955333
• MDR Text Key: 288272420
• Report Number: 3009211636-2022-00783
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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: 2104700166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1