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

Model Number	43303
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
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: the baby was returned to the mother to hold and it was noticed that the scalp picc line felt wet.The line was dried and reassessed 15 minutes later.The line was still damp and noted to be leaking and there were bubbles of fluid from the line.The line leaked 2cm from the statlock on the actual continuous picc line, not the extension set of line.The line was re-threaded without complications.
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 involved lot number could not be performed.However, all dhrs are reviewed to meet 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.Testing was performed on the returned sample.A visual inspection revealed that the catheter showed signs of use such as blood and it was identified that the catheter was broken below the butterfly.The physical sample evaluation revealed that the catheter has a leak at the end of the hub and shows marks of wear, causing the observed leak.Based on the customer report which states: ¿the device was inserted on (b)(6) 2023, in the nicu and removed on (b)(6) 2023¿ this information led to the conclusion that the damage of the device was not manufacturing related since the catheter was used on the patient and was evaluated for different causes such as man, material, equipment and there were no potential manufacturing process that could cause the catheter to break causing a leakage based on this investigation.There are no corrective actions required as the reported condition was not confirmed as manufacturing related.

• Brand Name: 1.9F ARGYLE SINGLE LUMEN PICC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 18005075
• Report Number: 3009211636-2023-00826
• Device Sequence Number: 6650487
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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
• Device Model Number: 43303
• Device Catalogue Number: 43303
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown