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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC SL KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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ARGON MEDICAL DEVICES INC. FIRST PICC SL KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Catalog Number 384232
Device Problem Insufficient Information (3190)
Patient Problem Phlebitis (2004)
Event Date 03/08/2018
Event Type  Injury  
Manufacturer Narrative
The device has not been returned for evaluation to date.If the device or images are submitted in the future, an evaluation will be performed.A follow-up report will be submitted at that time.
 
Event Description
One (1) catheter was used in the patient, presented phlebitis within the first 48h of use.
 
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Brand Name
FIRST PICC SL KIT
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key7405996
MDR Text Key104667928
Report Number1625425-2018-00029
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/14/2020
Device Catalogue Number384232
Device Lot Number11171028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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