MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

Model Number 26GA (1.9F) X 30CM

Device Problems Break (1069); Coagulation in Device or Device Ingredient (1096); Flushing Problem (1252); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the sample is available for evaluation.Argon is awaiting a response from the user facility.A follow-up report will be submitted once more information is available.

Event Description

New 1.9fr 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 1 cm.After the advance i attempted to flush 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 from the purple ¿strain relief¿ section while trying to flush and determine of line was clotted.This is the 3rd report of a broken argon 1.9fr picc.Two events are know to be from 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 reach put to manufacture to look for any recalls or knowledge of defective product.

Event Description

Follow up.

Manufacturer Narrative

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• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11456886
• MDR Text Key: 240620560
• Report Number: 1625425-2021-00861
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• Combination Product (y/n): N
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: 26GA (1.9F) X 30CM
• Device Catalogue Number: 384539
• Device Lot Number: 11320442
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other