• 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 SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM

  • 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 SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM Back to Search Results
Model Number 384221
Device Problem Material Rupture (1546)
Patient Problems Phlebitis (2004); Device Embedded In Tissue or Plaque (3165)
Event Date 05/01/2020
Event Type  malfunction  
Manufacturer Narrative
Argon has made three notifications for the return of the device for evaluation. As of the date of this report, the sample has not been returned. Without the sample or any visual evidence to review, the complaint cannot be confirmed. If additional information is received in the future, the complaint will be re-evaluated and a follow-up report will be provided as needed.
 
Event Description
On may 06 2020, we received a contact from the pharmacist from (b)(6) hospital and she informed our sales representative that they had a problem with our picc catheter, the same day i called her and the same reported that an (b)(6) patient underwent puncture with picc, introduced 25 cm, 5 days later they noticed the presence of phlebitis at the insertion site, went to draw the catheter and only left 5 cm, that is, the other 20 cm were inside the patient's vein, forcing the hospital to intervene invasively to remove the catheter. Surgical intervention was required to remove the catheter that was ruptured inside the vessel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM
Type of DeviceFIRST 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 Key10117002
MDR Text Key206809703
Report Number1625425-2020-00334
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model Number384221
Device Catalogue Number384221
Device Lot Number11286394
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/05/2019
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: 06/03/2020 Patient Sequence Number: 1
-
-