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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Model Number DIALYSIS UNKNOWN
Device Problem Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when the hemodialysis machine was turned on, the material had a problem with the flow and made it impossible to perform the procedure.The catheter was not repaired and there was no leak.The instructions of the manufacturing service for the use of the product was followed.There was no reported patient outcome.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
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
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key11331458
MDR Text Key231946017
Report Number3009211636-2021-00042
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDIALYSIS UNKNOWN
Device Catalogue NumberDIALYSIS UNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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