• 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, INC. FIRST PICC S/L CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

  • 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, INC. FIRST PICC S/L CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 384232
Device Problems Backflow (1064); Fluid Leak (1250); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/04/2020
Event Type  malfunction  
Event Description
Picc line leaking at hub while attached to fluid lines. Fluid backing up causing picc line to clot.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIRST PICC S/L
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd.
athens TX 75751
MDR Report Key10754778
MDR Text Key213660933
Report Number10754778
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot Number11328591
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/08/2020
Event Location No Information
Date Report to Manufacturer10/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-