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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC 26G (1.9F) 0.60MM X 30CM

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ARGON MEDICAL DEVICES INC. L-CATH PICC 26G (1.9F) 0.60MM X 30CM Back to Search Results
Catalog Number 384539
Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)
Patient Problems Infiltration into Tissue (1931); Pleural Effusion (2010)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
There were no samples or images available for review and a lot number was not provided. Without the sample to review, a definite root cause and corrective action cannot be established. If the sample is returned at a future date, the complaint will be reopened for further evaluation. Per the clinical education manual that argon maintains, causes related to this issue can be attributed to the handling of the device in the field. Potential causes of pleural effusion include: perforation of subclavian, brachiocephalic, or vena cava veins upon insertion of picc. Erosion of vein due to contact with catheter tip. This may be more likely to occur with left-sided approach from the upper body and the catheter not lying well within the svc. Infusion of hyperosmolar solutions/medications leading to chemical irritation and/or vein thrombosis. More common when tip is against vein wall. Combination of chemical and mechanical trauma to vein leading to erosion and effusion. Picc tip outside of superior vena cava. Blockage of thoracic or lymphatic duct by catheter or thrombus.
 
Event Description
Picc line that was pulled on a patient who ended up with pleural effusions due to a picc infiltration.
 
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Brand NameL-CATH PICC 26G (1.9F) 0.60MM X 30CM
Type of DeviceL-CATH PICC
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 Key6800514
MDR Text Key83172667
Report Number1625425-2017-00111
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number384539
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 Received07/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/17/2017 Patient Sequence Number: 1
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