MAUDE Adverse Event Report: CARDINAL HEALTH 1.9 FR ARGYLE DUAL LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43304
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: during use the 1.9 french double lumen picc line noted to be cracked right next to the purple plastic stabilizer.There was no harm to the patient.A new line was required.There was no harm to the patient.A new line was required.Additional information provided by the customer on 2/10/22 clarified that a leak occurred just above the butterfly where the extension tubing meets the butterfly.
Additional Manufacturer Narrative
The lot number was reported as unknown therefore a manufacturing device history record (dhr) review or product/process changes review for the reported lot number could not be assessed.In addition, all dhrs are reviewed to confirm all regulatory requirements prior to product release.One used catheter from an unknown lot number was received inside of a generic plastic bag for analysis and investigation.A visual inspection revealed that the catheter showed signs of use (such as residues of a white substance) and the catheter was broken just below the butterfly.Therefore, the event reported by the customer was confirmed.The physical sample evaluation did not detect a leak in the catheter.Based on the device being used, it is determined that the catheter was in good conditions prior use and the manufacturing process was reviewed and no potential causes contributing to the condition were found.The condition reported most likely occurred from not adhering to the ifu.According to a corrective/preventative action (capa) assessment, it has been determined that there is no capa related to the event reported in this complaint.No further actions are required as the reported condition was not confirmed as manufacturing related.

• Brand Name: 1.9 FR ARGYLE DUAL LUMEN PICC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16367916
• Report Number: 3009211636-2023-00807
• Device Sequence Number: 7370095
• Product Code: LJS
• UDI-Device Identifier: 10884527004652
• UDI-Public: 10884527004652
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/29/2023

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: 43304
• Device Catalogue Number: 43304
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/29/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown