Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. L-CATH¿ S/L PICC S/L; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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. L-CATH¿ S/L PICC S/L; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number 26GA (1.9F) X 30CM
Device Problems Fluid/Blood Leak (1250); Torn Material (3024)
Patient Problem Injury (2348)
Event Date 07/18/2017
Event Type  malfunction  
Event Description
Nurse was discontinuing a picc line that was no longer needed.She carefully removed the tape, cotton balls and opposites, one layer at a time.When she pulled back the cotton balls, she saw the picc line sitting on top, with it open and dripping iv fluid.It was quickly clamped it off, and nurse proceeded to remove the picc per protocol.The line had somehow become severed or ripped right up from the hub about 1 cm.The rest of line was intact.Temporary harm requiring intervention but no lasting issues with patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
L-CATH¿ S/L PICC S/L
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek road
athens TX 75751
MDR Report Key6753434
MDR Text Key81375612
Report Number6753434
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date01/06/2020
Device Model Number26GA (1.9F) X 30CM
Device Catalogue Number384539
Device Lot Number11162385
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/27/2017
Event Location Hospital
Date Report to Manufacturer07/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-