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

Model Number	43303
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Upon first assessment, blood was found backing up into the argyle single-lumen peripheral inserted central catheter (picc) line.The picc line felt wet and linen under infant wet.The treatment was paused and disconnected iv fluids and flushed line with normal saline.Fluid squirted out of the side of the picc line.After consulting with the health care providers, the picc line pulled and a new peripheral intravenous line inserted.

• Brand Name: ARGYLE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 12266240
• Report Number: 12266240
• Device Sequence Number: 4376779
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: (01)10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021
• Report Date (Section F): 07/26/2021

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: No Information
• Device Model Number: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 1905000059
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 DA
• Date Report Sent to FDA: 07/26/2021