• 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 8813793013
Device Problem Obstruction of Flow (2423)
Patient Problem No Patient Involvement (2645)
Event Date 08/05/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was obstruction found in the passage of the guide wire during catheter insertion. It was noted that the catheter was not repaired, there was no leak, no luer adapter issue and flushing was not done. It was stated that the occlusion was found next to the suture fin. There was no defect or damage found in the guide wire. Another kit was used to complete the procedure. There was no patient involvement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was obstruction found in the passage of the guide wire prior to catheter insertion. It was noted that the catheter was not repaired, there was no leak, no luer adapter issue and flushing was not done. It was stated that the occlusion was found next to the suture fin. There was no defect or damage found in the guide wire. The catheter was not inserted. Another kit was used to complete the procedure. There was no patient involvement.
 
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
MDR Report Key9109286
MDR Text Key159798567
Report Number3009211636-2019-00204
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004832
UDI-Public10884521004832
Combination Product (y/n)N
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/20/2022
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1717000107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-