MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. ARGON DOUBLE LUMEN 2.6 FR CVC PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number 384466

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2023

Event Type  Injury  

Event Description

2.6 fr picc (peripherally inserted central catheter) red lumen cracked on (b)(6) 2023.Lumen clamped and not used (blue lumen used until line removed) and picc (peripherally inserted central catheter) line discontinued on (b)(6) 2023.

• Brand Name: ARGON DOUBLE LUMEN 2.6 FR CVC PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.
• MDR Report Key: 16877087
• MDR Text Key: 314752204
• Report Number: MW5117279
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2023

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 Operator: Health Professional
• Device Model Number: 384466
• Device Lot Number: 11456642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 MO
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White