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

Model Number	43303
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 neonatal icu has reported that the argyle picc had issue related to luer lock being stripped.Additional information was received from the customer and stated that there were no issues initially with connecting at the luer lock on insertion, but over time it began to wear away and appeared to be stripped.The line has been indwelling for 14 days upon discovering the issue.The facility does tube change every 3 days.This baby had 4 tubing change done.Upon 4th tubing change, the nurse noticed loose connection, but the infant was not stable for line to be pulled.There was no issue with the catheter connection with the butterfly.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2405900124 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
• Manufacturer (Section G): CARDINAL HEALTH, INC.; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20049535
• Report Number: 1423537-2024-00124
• Device Sequence Number: 15448090
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: (01)10884527004645(17)290219(10)2405900124
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 2405900124
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/07/2024
• 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