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 ACCURA BLN 20GA X 5CM
  • 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 ACCURA BLN 20GA X 5CM Back to Search Results
Model Number BLN2005
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Event Description
The patient underwent thoracoscopic lung cancer surgery for lung cancer, and the positioning needle under ct is needed before surgery.At the beginning of the operation, if it is found that the positioning needle has been broken, take out the broken puncture needle immediately.
 
Manufacturer Narrative
The device is not available for return, however, images were provided.Investigation is still ongoing.A follow-up report will be submitted once the investigation is completed.
 
Manufacturer Narrative
According to the product experience report, there was no sample to be returned.The photo returned with the complaint does show that the needle is separated from the cannula hub.The complaint is confirmed.However, without a physical sample, a more thorough investigation to find a root cause cannot be conducted.
 
Event Description
The patient underwent thoracoscopic lung cancer surgery for lung cancer, and the positioning needle under ct is needed before surgery.At the beginning of the operation, if it is found that the positioning needle has been broken, take out the broken puncture needle immediately.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCURA BLN 20GA X 5CM
Type of Device
ACCURA BLN
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12817100
MDR Text Key283784671
Report Number0001625425-2021-01123
Device Sequence Number1
Product Code GAA
UDI-Device Identifier00886333007509
UDI-Public00886333007509
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation 505
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBLN2005
Device Lot Number11308398
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-