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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 Product Quality Problem (1506)
Patient Problem Unspecified Infection (1930)
Event Date 10/11/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, on (b)(6) 2021 and (b)(6) 2021, the patient had catheter placements. It was said that on (b)(6) 2021, during use of both catheters, catheter-related bloodstream infection (crbsi) occurred. The catheters were not repaired and had no leak. Iodopovidone was the cleaning agent used for both devices. Tego was not utilized. There were no luer adapter issues.
 
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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
MDR Report Key12737760
MDR Text Key279578378
Report Number3009211636-2021-00308
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
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813817009
Device Catalogue Number8813817009
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2021 Patient Sequence Number: 1
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