• 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 Problems No Consequences Or Impact To Patient (2199); Unintended Radiation Exposure (4565)
Event Date 07/15/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when the first catheter was used, there was implantation problem with difficulty in passing the guide wire. During the flow test at the time of implantation, after the implantation and during the treatment, there was low flow and catheter dysfunction. It was mentioned that this was in the infusion line. It was necessary to use more than one catheter for the same implant (the catheter was replaced by 2 new catheters which also presented the same problem). The catheter were not repaired and there was no leak. No cleaning products was used for the catheter, the catheter was sterile. Tego was not utilized and there was no luer adapter issue. There was no problem with the size of the catheter and there was no occlusion. The guide wire used was the one included in the kit and the product was still sealed upon receipt. There was no damage to the device's box and packaging. There was no excessive force used to pull/remove the product. Flushing was done and had no problems. The tube was not difficult to rinse with the syringe and there was blood return before washing with the syringe. Heparin was used as a blocking solution after implantation. The reverse flow was not successful. There were no other products being utilized with the device and there were no other defects/damages found in the product. There was no leak or bleeding and blood transfusion was not required. There was no intervention/treatment necessary as a result of the event. It was not necessary to remove the guide wire and catheter from the patient simultaneously (in one action) due to the alleged defect. When the guide wire was removed, it was deformed, but it was not frayed. X-ray was performed. Although it difficult and took longer than usual, they managed to get through the guide wire through and solve the low flow and catheter dysfunction issues by using a new product from another brand. The procedure was completed.
 
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 st.
mansfield, MA 02048
2034925563
MDR Report Key10662874
MDR Text Key211054528
Report Number3009211636-2020-00246
Device Sequence Number1
Product Code FOZ
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 Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number1911300208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2020 Patient Sequence Number: 1
-
-