• 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. 1ST PICC S/L 26GA

  • 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. 1ST PICC S/L 26GA Back to Search Results
Catalog Number 384232
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2016
Event Type  malfunction  
Manufacturer Narrative
The device history record could not be reviewed because the lot number was not provided. There was no patient injury. The picc broke and had to be removed. Visual inspection of returned product confirmed the breakage, which occurred just below the nose of the overmolded extension set. The area of separation was reviewed under magnification. The tubing appeared to have been fully formed (no voids were noted). The edges of the separated tubing were jagged which is characteristic of undue force to the catheter. Potential times at which this force may have been applied to the catheter include: flushing the catheter with excessive pressure, such as flushing with a syringe smaller than 10 ml, or applying pressure despite resistance when flushing. Using the catheter for high pressure mechanical injection. Advancing or removing the catheter despite experiencing resistance. The ifu includes the following guidelines to inform clinicians of these causes and mitigate the occurrence of breakage: "use a 10 ml syringe design to flush the catheter. Do not use force to flush the catheter as a 10 ml syringe design has the potential to generate high pressure (greater than 40 psi) capable of rupturing the catheter. " "never use force to flush the catheter if resistance is met. " "never use the catheter for high-pressure injection. Syringes smaller than 10 ml and mechanical high-pressure injectors can generate pressures capable of rupturing the catheter. " this complaint may be related to the handling of the device in the user environment.
 
Event Description
The picc broke off just below argon label. Picc was removed all of catheter was intact. Piv was inserted after this product was discontinued so the patient was able to complete the prescribed therapy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name1ST PICC S/L 26GA
Type of Device1ST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES, INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key5515320
MDR Text Key41075841
Report Number1625425-2015-00098
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384232
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-