• 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 8813817009
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intra-operatively, after cannulating internal jugular vein, guide wire was introduced into the patient, and when the guide wire was passed though the venous tip of the catheter, the wire was stuck and did not come out of the blue end of the catheter. It was stated that the wire was stuck at the hub of the catheter. It was reported that there was no leak, the catheter was not repaired, tego was not utilized and chlorahexadine solution was the cleaning agent used, there were no luer adapter issue and the insertion site was treated prior to product placement. There was no reported patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received photographs of one device. The visual inspection of the returned photographs depict the first image of the guide wire inserted into the distal end of the catheter. The second image depicts the packaging label. Post market vigilance (pmv) led an evaluation of one device. Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. If information is provided in the future, a supplemental report will be issued.
 
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 Key8573766
MDR Text Key143841016
Report Number3009211636-2019-00114
Device Sequence Number1
Product Code FOZ
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,foreig
Type of Report Initial,Followup,Followup
Report Date 07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/17/2021
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1625900026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-