MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 384232

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/28/2022

Event Type  malfunction  

Event Description

Peripherally inserted central catheter (picc) line noted to be snapped at the heart of the line during routine assessment of the line.

• Brand Name: FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek roadv; athens TX 75751
• MDR Report Key: 15454348
• MDR Text Key: 300232651
• Report Number: 15454348
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: 11413331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA
• Patient Weight: 4 KG