MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ARGON 1.9FR PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30 CM

Device Problems Break (1069); Coagulation in Device or Device Ingredient (1096); Difficult to Flush (1251); Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2020

Event Type  No Answer Provided  

Event Description

New 1.9 fr peripherally inserted central catheter (picc) placed, it was a tough insertion with a slow advance of the catheter.After checking for blood return the catheter was flushed with normal saline (ns) and a temporary dressing placed for kidneys, ureters, bladder (kub) imaging.Line was at t12, attempted to advance catheter under sterile conditions 1cm.After the advance i attempted to flush the line again and it would not aspirate or flush.During the final attempt to flush the catheter broke at the purple strain relief and the hub.I attempted to rewire the line, but ultimately lost the line.Line clotted in between placement and kub imaging.Leave a sterile flush attached to the line + temporary dressing and flush every 5 minutes to keep patient.Picc catheter separated luer hub from purple "strain relief" section while trying to flush and determine if line was clotted.This is the 3rd report of a broken argon 1.9fr picc.Two events are know to be from the same lot number (11320442).Our group (who insert a majority of the 1.9fr piccs for our patients) have discussed pursuing a vygon 2.0fr picc product as an alternative.Supply chain escalated and reaching out to manufacture to look for any recalls or knowledge of defective product.This is all the information available.

• Brand Name: ARGON 1.9FR PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 11285003
• MDR Text Key: 230467877
• Report Number: 11285003
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30 CM
• Device Catalogue Number: 384539
• Device Lot Number: 11320442
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 DA