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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

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ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN Back to Search Results
Catalog Number 384232
Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546)
Patient Problems Extravasation (1842); Pericardial Effusion (3271)
Event Date 11/24/2017
Event Type  malfunction  
Manufacturer Narrative
There were no samples available for review; however, a lot number was provided. A review of the device history record and inspection records was conducted and similar concerns were found. Without the sample to review, a definite root cause cannot be established. First picc catheters are 100% in-process inspected at various times during manufacture. Catheters are also leak, flow, and burst tested to ensure their integrity. Additionally, the instructions for use indicate several ways users can prevent catheter damage.
 
Event Description
Picc catheter presented extravasation (rupture) after 2 days of insertion. What in one patient led to a pericardial effusion.
 
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Brand NameFIRST PICC 26GA, SINGLE LUMEN
Type of DeviceFIRST 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 Key7162282
MDR Text Key96819591
Report Number1625425-2017-00180
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2020
Device Catalogue Number384232
Device Lot Number11173915
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 Received12/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2017
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: 01/03/2018 Patient Sequence Number: 1
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