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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793013
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/05/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during the procedure, the catheter had a fissure or crack in the arterial route/pathway compromising its functioning.The use of the product followed the manufacturer's instructions.There was no reported patient outcome.
 
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Brand Name
MAHURKAR
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12302301
Report Number3009211636-2021-00203
Device Sequence Number17270103
Product Code FOZ
UDI-Device Identifier10884521004832
UDI-Public10884521004832
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K943349
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/10/2023
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1803700089
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2021
Initial Report FDA Received Date08/10/2021
Date Device Manufactured02/10/2018
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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