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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC SL KIT CATH,INTRAVASC,THERAP,SHORT-TERM LESS 30DAYS

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ARGON MEDICAL DEVICES INC. FIRST PICC SL KIT CATH,INTRAVASC,THERAP,SHORT-TERM LESS 30DAYS Back to Search Results
Catalog Number 384232
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Phlebitis (2004)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative
The device was still in use; therefore, no evaluation of the device could be performed. No further information has been ascertained in relation to the patient's status. If further information is obtained in the future, a follow-up report will be submitted.
 
Event Description
First picc s/l demonstrated early signs of phlebitis. The md instructed primary care rn to apply heat for one hour and discovered mild improvement from the vein. The catheter is currently in place until further evaluation. The catheter was inserted on (b)(6) 2018 and trimmed to 12 cm.
 
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Brand NameFIRST PICC SL KIT
Type of DeviceCATH,INTRAVASC,THERAP,SHORT-TERM LESS 30DAYS
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
4697311415
MDR Report Key7547275
MDR Text Key109357426
Report Number1625425-2018-00054
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number384232
Device Lot Number11206023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/27/2018 Patient Sequence Number: 1
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