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 FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
  • 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 S/L 26GA (1.9F) 0.65MM X 50CM Back to Search Results
Model Number 384232
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombus (2101)
Event Date 04/27/2020
Event Type  Injury  
Manufacturer Narrative
As of the date of this report no samples or visual evidence has been provided for evaluation.Without such evidence, the complaint cannot be confirmed.If additional information is received in the future, the complaint will be re-opened and investigated as needed.
 
Event Description
No change in picc insertors.No change in providers.No lot# available.Do not believe it¿s a lot# issue due to product rotation.Over the past 18 months we have had an increase in picc related thrombus.Patient with picc had palpable cords, the picc pulled, next day ultrasound shows thrombus, all been dvts and had to be treated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
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 Key10067881
MDR Text Key195100892
Report Number1625425-2020-00323
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209750
UDI-Public00886333209750
Combination Product (y/n)N
PMA/PMN Number
K972262
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 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384232
Device Catalogue Number384232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-