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

Model Number	8888160648
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a 39.3 week gestation infant was admitted in newborn intensive care unit (nicu) for meconium aspiration with respiratory symptoms (mas) and was emergently intubated.A triple lumen catheter was placed in the infant by a neonatal nurse practitioner (nnp) and was noted to be leaking consistently in line (hole/crack in it).The line was immediately removed, and another line was placed.Per customer, there was no injury or adverse reaction occurred to the patient involved.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used catheter and few pictures were received for analysis.Upon visual inspection, the catheter showed signs of use (such as residues of blood) and was identified that the catheter was broken on its tube.Additionally, during the physical/ functional evaluation, the returned sample was submitted to underwater test and a leak was identified in the section of the tube near the number 10 marking when the primary extension was connected and tested, the other two extensions (secondary and tertiary) did not present any deviations.Therefore, the reported issue is confirmed.The customer stated that ¿a leak was discovered, when the catheter was used on the patient, after insertion¿.Based on the customer provided information, the leaking was noticed after insertion of the catheter.The device was in good condition prior to use, when flushing and placing it, and not correctly following the instructions for use/ indicated use could contribute to the catheter damage during use.During investigation, no manufacturing related potential cause was identified.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for qa tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER TRIPLE LUMEN 5FR
• Common Device Name: 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: 17248565
• Report Number: 3009211636-2023-00819
• Device Sequence Number: 17342241
• Product Code: FOS
• UDI-Device Identifier: 20884527005199
• UDI-Public: 20884527005199
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8888160648
• Device Catalogue Number: 8888160648
• Device Lot Number: 2230000118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/18/2023
• 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: Male