• 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 02/21/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intraoperatively, the guide wire was stuck while inserting into the patient. It was reported that the guide wire did not come out of the venous (blue) ultem adapter. They had to use a fresh catheter to continue. The catheter was not repaired, there was no leak, alcohol based chlorohexadine solution was the cleaning agent used, there was no luer adapter issue, tego was not utilized. There was no reported patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device. The visual inspection of the returned photos noted: the first image depicts the red luer adapter, extension tube ,clamp and guide wire in the packaging bag. The second image depicts the catheter and guide wire in the packaging bag. The guide wire is inserted into the cannula. Without the physical device functional evaluation is precluded. 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 Key9808190
MDR Text Key194372412
Report Number3009211636-2020-00062
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,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1828400123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No

-
-