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

MAUDE Adverse Event Report: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

  • 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
 

FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Complete Blockage (1094); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray. Device catalog number: c-utlmy-501j-lsc-abrm-hc-ihi-fst. Reporter occupation: clinical product specialist. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that the red lumen of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was unable to be flushed prior to patient contact. Prior to inserting the device into the patient, the physician was flushing the lines to verify patency. While doing so, it was noted that one of the hubs was unable to be flushed, specifically the red-colored one. A new device was obtained and successfully inserted without incident. No adverse effects to the patient have been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key11874092
MDR Text Key253037266
Report Number1820334-2021-01389
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
PMA/PMN Number
K033843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
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
Type of Device Usage Initial

-
-