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

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR 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
 

COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793009
Device Problems Difficult to Advance (2920); Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, it was stated that the catheter had problems in the efficiency of supply of blood flow during hemodialysis. After the insertion with initial flow and with adequate care, it does not allow good flow even in the medium term, which necessitates frequent device changes. The guide wire was inadequate, necessitating opening of another device just to use the guide wire. There was no reported patient outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key8791115
MDR Text Key151126036
Report Number3009211636-2019-00165
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004801
UDI-Public10884521004801
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/25/2022
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number1713900127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-