MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SINGLE LUMEN 5FR; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the patient was being held when the family noticed blood backing up into the line and dripping outside of the tubing suddenly.She hit her call light and the staff came to the bedside to assess.There was a crack in the umbilical venous catheter (uac) lumen.This crack was not present earlier in the shift as the staff had been using the line for labs.The staff notified the advanced practice nurse (apn) who then came to bedside to remove the line.There was no patient harm reported.Additional information was received and stated that it being a very slow drip, might be a total of 1-2cc of blood dripped before she was able to get to bedside to remove the line.Per customer, the device was removed on (b)(6) 2022, and was not replaced.

Event Description

The customer reported that the patient was being held when the family noticed blood backing up into the line and dripping outside of the tubing suddenly.She hit her call light and the staff came to the bedside to assess.There was a crack in the umbilical venous catheter (uac) lumen.This crack was not present earlier in the shift as the staff had been using the line for labs.The staff notified the advanced practice nurse (apn) who then came to bedside to remove the line.There was no patient harm reported.Additional information was received and stated that it being a very slow drip, might be a total of 1-2cc of blood dripped before she was able to get to bedside to remove the line.Per customer, the device was removed on (b)(6) 2022, and was not replaced.Further information was received and stated that per customer, povidone iodine was used to clean the skin area prior to insertion.The line was secured with tegaderm and the ¿goal post¿ securement device.The device was inserted on (b)(6) 2022.The customer further stated that the lines would have been flushed with labs or if the patient received intermittent iv medications.They also run heparinized fluids through each lumen to keep lines patent.Per customer, 1 ml of normal saline in a 10 ml syringe was used to flush each time.The patient has been discharged from the hospital.

Manufacturer Narrative

Section d6a / d6b field has been updated to include the device implant and explant date.Section b5 has been updated to include additional information.

Manufacturer Narrative

Since a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used catheter from an unknown lot number was received inside a generic plastic bag for investigation.Upon visual evaluation, the catheter did not show signs of use.The physical sample evaluation was performed and revealed that the sample showed bubbles during underwater test.The catheter showed on its extension a crack where the air escapes and bubbles were identified.Therefore, the reported issue is confirmed.Based on the analysis, the issue was identified during the physical evaluation of the patient and the incident description states as ¿this crack was not present earlier in the shift as the staff had been using the line for labs¿.Based on the investigation, it was determined that the catheter was in good conditions prior to use.Also, manufacturing process was reviewed and no potential causes contributing to the reported issue were found.Based on the review of instructions for use (ifu) and replica done, it was determined that not correctly following the instruction for use is the most probable root cause of the reported issue.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SINGLE LUMEN 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: 15996144
• MDR Text Key: 307993364
• Report Number: 3009211636-2022-00803
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005123
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• 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 Age: 1 WK
• Patient Sex: Female