MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. ARGON PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number 384539

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Erythema (1840)

Event Date 10/21/2019

Event Type  malfunction  

Event Description

Picc inserted on (b)(6) 2019 at 1615; 1.9 fr argon l-cath lot number #11270595, exp 08/05/2022.Inserted into brachiocephalic vein.Insertion length 11 cm and total length of picc is 13 cm.Erythema started around 2 pm on (b)(6) 2019.Erythema and edema present at 1530.Order to dc and dc'd picc at 1500.Rns state the picc line was being discontinued in a slow steady motion, without difficulty.The entire picc line was removed from the pt.No diagnostics were required to determine this.Fda safety report id# (b)(4).

• Brand Name: ARGON PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.
• MDR Report Key: 9271817
• MDR Text Key: 165212824
• Report Number: MW5090852
• 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: 10/30/2019

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 Expiration Date: 08/05/2022
• Device Catalogue Number: 384539
• Device Lot Number: 11270595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1