• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

  • 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
 

ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25703-E
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "medical doctor was performing the procedure according to ifu. Md found that the j-tip guide wire was bent and stretched when pushed with a little force for insert. So md judged as defective product and finished the procedure using new product". It was reported "the j-tip guide wire sags". No patient harm reported. The patient's condition is reported as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12260271
MDR Text Key264535262
Report Number3006425876-2021-00716
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCS-25703-E
Device Lot Number71F20J1357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-