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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

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793009
Device Problems Defective Component (2292); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received. The device was available for evaluation. The evaluation found no potentially contributing factors, and the sample met all related specifications. It was reported that there was an issue with the catheter dimension. The reported issue could not be confirmed. The most likely cause could not be identified because no related problem was detected with the device. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during visual inspection and test, the catheter's middle part blocked and could not be inserted. It was stated that flushing was done but it was failed. The device was exchanged with a new one and the treatment was done to resolve the issue. There were no other products being utilized with the device. There were no other defects/damages found on the product observed. It was stated that the catheter match what is indicated on the label. There was no packaging damaged. There was no reported patient injury.
 
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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
CS 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS 20101
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key12110317
MDR Text Key259981013
Report Number3009211636-2021-00158
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793009
Device Catalogue Number8813793009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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