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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MANUF. SOLUTIONS SA 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 Patient Involvement (2645)
Event Date 03/01/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 17/apr/2017. An investigation is currently underway; upon completion the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states prior to use on a patient the lumen was found to be obstructed.
 
Manufacturer Narrative
This complaint has not been confirmed. The actual sample involved in the reported incident was not returned for evaluations. No additional information, pictures or videos were received. Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation. A manufacturing device history record (dhr) review or product/process changes review for the involved lot number was performed. No deviations that could be related to the reported event were found. All dhrs are reviewed for accuracy prior to product release. No additional information was received for investigation. If the sample is returned in the future, this complaint will be re-opened for further investigation. The available information was analyzed and it did not allow confirming a root cause for the event, however, brainstorming was performed in order to identify the possible causes for the failure. The following potential causes were identified: operator inattention, misuse, inspection failed or not performed, or defective material. No trends or triggers have been found, therefore, a corrective or preventive action (capa) is not deemed necessary at this time. It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes.
 
Event Description
The customer states prior to use on a patient the lumen was found to be obstructed.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MANUF. SOLUTIONS SA
edificio 820 calle#2
zona franca coyol
alajuela 20101
Manufacturer (Section G)
COVIDIEN MANUF. SOLUTIONS SA
edificio 820 calle#2
zona franca coyol
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire st
mansfield, MA 02048
5084524151
MDR Report Key6497036
MDR Text Key72931688
Report Number3009211636-2017-05080
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2020
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1506100145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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