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

Model Number	8888160531
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the umbilical catheter is a struggle to insert.They are soft, kink easily, and flimsy.The two-lumen color visibility is an issue to see when the baby is in meco with the light on.There is no clamp to clamp the lumen when needed.After insertion, the doctor was unable to withdraw blood back.The worst part is after the line was removed, it broke.About 6cm of the line remained in the umbilical area.This was detected after x-ray.Afterwards they were able to remove the broken catheter with no harm to the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were 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.No manufacturing or design issues were identified.Controls are in place to prevent non-confirming product from leaving manufacturing operations.As such, the root cause could not be determined based on available information.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.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
• 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: 14415024
• Report Number: 3009211636-2022-00788
• Device Sequence Number: 5551208
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2026
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 2123100099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown