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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. FIRST PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 384516
Device Problem Insufficient Information (3190)
Patient Problem Pleural Effusion (2010)
Event Date 05/05/2016
Event Type  malfunction  
Event Description
Infants with picc's developed infiltrates and/or pleural effusion. Four episodes to date. Hospital performing root cause analysis (rca).
 
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Brand NameFIRST PICC
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 Key5750684
MDR Text Key48229469
Report Number5750684
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384516
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2016
Event Location Hospital
Date Report to Manufacturer06/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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