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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES, INC. FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 384232
Device Problems Fluid Leak (1250); Fracture (1260); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2020
Event Type  malfunction  
Event Description
While attempting a picc insertion, rn threaded catheter through introducer into vessel and the line would draw and flush without difficulty. When attempted to advance catheter 2cm, catheter buckled under skin. Rn attempted to draw and flush line again and catheter then was leaking clear fluid out of the insertion site. When withdrawing the catheter out of the body, rn noted the catheter to be slightly fractured and then completely snapped in two parts when attempt was made to cut catheter segment for this report. All cm were accounted for 15 total, therefore no cm left inside body.
 
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Brand NameFIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd
athens TX 75751
MDR Report Key10118291
MDR Text Key193947963
Report Number10118291
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot Number11286356
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2020
Event Location Hospital
Date Report to Manufacturer06/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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