MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 384539

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2002

Event Type  malfunction  

Event Description

L-cath picc s/l 26 gauge inserted into patient; after insertion noted that it was leaking.Once removed, identified a crack that was the root cause.Fda safety report id# (b)(4).

• Brand Name: L-CATH PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.
• MDR Report Key: 14547593
• MDR Text Key: 293145679
• Report Number: MW5109979
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2022

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 Catalogue Number: 384539
• Device Lot Number: 11405477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1