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

Model Number 8888160333

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2023

Event Type  Injury  

Event Description

The customer reported that the uvc was seen to be malpositioned on kub.The umbilical area was cleaned and prepped with betadine.A time out was performed at 6pm.The line was removed 2cm to 6cm.On repeat kub the catheter still appeared malpositioned.Upon a second attempt to further adjust the line separated from itself.It separated at approx.4.5cm mark.The retained piece was unable to be visualized at the stump.A kub was obtained, revealing a piece of catheter.Dr.(b)(6) and the nicu fellow were notified.Dr.(b)(6) called the interventional cardiology attending, the pediatric surgical attending and the cardiac anesthesia attending.Dr.(b)(6) also spoke in person to the parents.Additional information received on 02aug2023 stated that the uvc was first placed on (b)(6) 2023.The retained piece was in the umbilical vein.They removed the retained piece by dilation of umbilical vein, surgical method in the or.The infant required intubation for the procedure.They stated it was "hours" between noticing the separation and removing the piece.There was no injury or harm to the patient due to this incident.The catheter was not curled inside the patient.The patient's weight: 1.35kg.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the information available to us, we were able to confirm the event, and determined that: the returned catheter was shown to be split in two sections near the 5cm mark.However, based on the event description, it was determined that the catheter was in good condition prior to use.After reviewing all available information and reviewing the manufacturing process, an exact root cause could not be determined at this time.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.All information received will be used for further 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: 17447281
• MDR Text Key: 320286585
• Report Number: 3009211636-2023-00821
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male