• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC & L-CATH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARGON MEDICAL DEVICES FIRST PICC & L-CATH Back to Search Results
Catalog Number 384232
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Pleural Effusion (2010)
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative
A review of the dhrs and inspection records were conducted and no similar concerns were found. Causes for pleural effusion include incorrect catheter tip placement and catheter migration (due to improper securement). This account does not employ an engineered securement device (i. E. Statlock) for the 384232, which can help keep the line in the right location. It was determined that the root cause of this complaint was not a catheter issue but was related to securement techniques by the healthcare facility. Current plans are to conduct care and maintenance training with this customer.
 
Event Description
On (b)(6) 2016 patient was diagnosed with a pleural effusion. Dressing/securement was with tegaderm and tape only. No engineered securement device used, no bio patch used. New l cath 26 ga picc was placed on (b)(6) 2016 and had to be removed the next day because of redness of a red streak.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIRST PICC & L-CATH
Type of DeviceFIRST PICC & L-CATH
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key5764868
MDR Text Key48640778
Report Number1625425-2016-00030
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 07/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number384232
Device Lot Number11095703
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 Received06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2015
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: 07/01/2016 Patient Sequence Number: 1
-
-