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 L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM
  • 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 L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM Back to Search Results
Model Number 28 GA (1.2F) x 25cm
Device Problem Complete Blockage (1094)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, it has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
Picc was inserted on (b)(6) 2020.The picc had a dwell time of 4 weeks then the picc occluded.Picc removed.New 1.2 fr picc inserted.The lot# is either 11288259 or 11295144.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM
Type of Device
L-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 Key10653517
MDR Text Key212110247
Report Number1625425-2020-00602
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209910
UDI-Public00886333209910
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 Nurse
Remedial Action Other
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number28 GA (1.2F) x 25cm
Device Catalogue Number384516
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/08/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-