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

Model Number 8888160531

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2022

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

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
• 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: 14415024
• MDR Text Key: 291803936
• Report Number: 3009211636-2022-00788
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other