• 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 PICC POLYURETHANE SINGLE LUMEN, 28G (1.2FR) X 25CM L-CATH PICC

  • 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 PICC POLYURETHANE SINGLE LUMEN, 28G (1.2FR) X 25CM L-CATH PICC Back to Search Results
Catalog Number 384540
Device Problem Fluid Leak (1250)
Patient Problems Cellulitis (1768); Phlebitis (2004); No Code Available (3191)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device used is indicated as available for evaluation. As of the date of this report, the sample has not yet been returned. A follow-up report will be provided once the sample has been received and reviewed.
 
Event Description
Significant catheter leakage (3 occurrences with the same patient and at least one other). Very rare problem, 3 different experienced inserters. Red track along the course of the vein, difficult withdrawal from the saphenous, oedema in the limb. Different location in each case. Patient presented with probable superficial hardening/cellulites/phlebitis following dwell times of 11, 3 and 3 days. The inserting mds believe that the catheter is getting stuck in the splittable introducer needle, which affects permeability, and that breakage may occur. Total number of leaking catheters: 4; total number of needles: 6.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePICC POLYURETHANE SINGLE LUMEN, 28G (1.2FR) X 25CM
Type of DeviceL-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10391121
MDR Text Key203476499
Report Number1625425-2020-00473
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384540
Device Lot Number11292771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/11/2020 Patient Sequence Number: 1
-
-