MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 their neonatal icu site has incorrect connectors for the 3.5fr single lumen umbilical catheters.The hub has two notches that do not connect with their syringes or tubing.While trying to connect the line, the practitioners kept turning the catheter but were unable to get it to connect properly.Additional information was received from the customer and stated that unable to fully secure a bd 5 ml syringe onto uvc luer ¿lugs¿.The issue occurred during 1st access with syringe.The customer verified manually and noticed that threads were not engaging with syringe luer.The luer lugs appeared to be bent away from luer, when compared with component design.The nurses evaluated the other uvc products from the same lot and connection with syringe seemed to function as intended.They were able to successfully connect a syringe or other device, without an issue.A nurse also evaluated attaching the exact 5 ml syringe used in the reported complaint to one uvc luer from the same lot (not the subject of complaint) and said it connected to the new uvc acceptably and no issue observed.This infers that the syringe used was not to blame.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2410500063 was reviewed and no anomalies related to the reported issue were observed.A video and a few pictures were received for evaluation and the reported condition was observed.A corrective and preventive action has been initiated to further investigate this issue.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19982081
• Report Number: 1423537-2024-00112
• Device Sequence Number: 8375340
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: (01)20884527005113(17)290314(10)2410500063
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K130725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2410500063
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/06/2024
• 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: Unknown