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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 8813817009
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, before inserting catheter on the patient, they tried to flush with ns (normal saline) and it was found that the arterial lumen was blocked. They also tried with a guide wire and the guide wire was not passing. The customer did not try to reverse the lines. The device was not used. The procedure was successful and completed with another catheter kit (from their stock). There was no problem with the catheter's dimension. The dimension of the catheter matched what was indicated on the label. No other products being utilized with the device. Nothing unusual observed aside from reported issue. No other defects/damages found on the product. No solution or agent was used on the insertion site. The catheter was not repaired. There was no leak. No cleaning agent used on the device. Tego was not utilized. There was no luer adapter issue. There was no blood loss. Blood transfusion was not required. No intervention/treatment required as a result of the event. There was no 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
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key12312780
MDR Text Key266206184
Report Number3009211636-2021-00209
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1927500113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
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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