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

Model Number	43309
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when staff attached the new tubing, it would constantly rotate but would not secure.They then tried a different anti-reflux and the same thing happened.Picc was inserted under sterile conditions and placement confirmed with x-ray.When hooking up to iv fluids, noted that the hub of the catheter was defective/broken and anti-reflux valve, flush, etc would not screw on tightly and lock in place.With no way to ensure that the line would not be disrupted/exposed, picc needed to be replaced.The customer provided the lot information for the picc within the insertion kit as well: product 43303, lot 2221100054, exp 2027-06-30.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Sections d4 udi was corrected from (b)(4).
Additional Manufacturer Narrative
The device history record (dhr) for lot 2412400080 was reviewed and no anomalies related to the reported issue were observed.The device was 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,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085 ; CS 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: 22742764
• Report Number: 1423537-2025-00310
• Device Sequence Number: 8506865
• Product Code: LJS
• UDI-Device Identifier: 10884527004676
• UDI-Public: (01)10884527004676(17)250930(10)2412400080
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K132567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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 Expiration Date: 09/30/2025
• Device Model Number: 43309
• Device Catalogue Number: 43309
• Device Lot Number: 2412400080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/08/2025; 09/11/2025
• 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