MAUDE Adverse Event Report: CARDINAL HEALTH, INC ARGYLE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: foz.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported they found that the picc line was not attached to the flange/hub.The line was separated.Per customer, thumb was placed on the line to keep device external to the patient and stopped the infusions.The issue was reported to the resident, attending, certified registered nurse (crn), and the pharmacy.The crn pulled the picc and placed the device in a sterile container.Additional information was received from the customer and stated that the picc was inserted on (b)(6) 2025, and the incident occurred on (b)(6) 2025.There was a delay in treatment and a new picc was inserted as a result.The patient is currently stable.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2314900168 was reviewed and no anomalies related to the reported issue were observed.A device was received for evaluation, and the reported condition was observed.The root cause appears to be misalignment during the bonding process.A quality alert has been issued, and manufacturing personnel have been notified for awareness.No corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• Brand Name: ARGYLE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 23352174
• Report Number: 1423537-2025-00426
• Device Sequence Number: 13028371
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: (01)10884527004645(17)280806(10)2314900168
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 2314900168
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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