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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. ARGON PICC CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
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).
 
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Brand NameARGON PICC
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
MDR Report Key9271817
MDR Text Key165212824
Report NumberMW5090852
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384539
Device Lot Number11270595
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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