MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ARGYLE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	43304
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the double lumen picc leaked at second lumen under hub closest to patient.Neonatal nurse practitioner (nnp) was notified, the picc was discontinued, blood culture for piv insertion was sent, vancomycin x1 given.The customer further stated there was no patient harm reported.Additional information was received from the customer and stated that they believe that the vancomycin was given prophylactically when the line was discovered to be leaking.The customer also mentioned they don't have any additional information on the blood culture report.
Additional Manufacturer Narrative
Additional product code (section d2a): ljs.An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2509000181 was reviewed and no anomalies related to the reported issue were observed.The device was received for evaluation and the reported condition was observed; however, a definitive root cause could not be determined.Based on this information, 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,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 24571420
• Report Number: 1423537-2026-00067
• Device Sequence Number: 8355349
• Product Code: FOZ
• UDI-Device Identifier: 10192253040234
• UDI-Public: (01)10192253040234(17)300307(10)2509000181
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K132567
• 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): 05/12/2026

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: 43304
• Device Catalogue Number: 43304
• Device Lot Number: 2509000181
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/12/2026
• 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