MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. ARGON 1.2 FR PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 11291561

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)

Patient Problem Tissue Breakdown (2681)

Event Date 04/12/2020

Event Type  malfunction  

Event Description

At 1200 assessment picc line was noted to have tpn under the dressing and dressing was wet.Np was called to bedside and attempted to flush and replace extension and unable due to leaking at hub of picc during flush.This picc was inserted on 03/21 and had required 10 dressing changes in the 22 days it was in place due to skin breakdown underneath and problems with dressing adhering to denuded skin.Fda safety report id # (b)(4).

• Brand Name: ARGON 1.2 FR PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.
• MDR Report Key: 10118746
• MDR Text Key: 194171576
• Report Number: MW5094836
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 11291561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 2