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

Model Number	8888160531
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the infant had a dual lumen uvc placed on admission.During night shift of 1/30 it was noted to be leaking at the junction of the catheter and the hard plastic hub.The line was removed and saved.
Additional Manufacturer Narrative
A review of the device history records (dhr) was not possible since the lot number was identified as unknown, however all dhrs are reviewed to confirm all regulatory requirements prior to product release.One used catheter with an unknown lot number and product code id 8888160341 was received inside of a generic plastic bag for investigation.According to the testing performed on the sample, visually it shows evidence that the catheter was used due to blood residue and two adaptors that were included and do not belong to the original product.During a leak test of the sample bubbles formed because of a broken catheter in the strain relief.Therefore, the reported condition was confirmed.As the device was already used on the patient it had already been flushed prior use.Based on this it is concluded that when flushing the device prior to inserting it to the patient, it did not show the reported condition, meaning that the device was in good condition prior to use.The condition reported most likely occurred because of manipulating the device during use.In addition, it was observed that the catheter has previous manipulation, due to a cut and a green adapter in the extension that has a metallic object.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 performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR DUAL-LUMEN UVC CATH
• Common Device Name: 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: 13563320
• Report Number: 3009211636-2022-00775
• Device Sequence Number: 11876514
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown