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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 8813793009
Device Problems Detachment Of Device Component (1104); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary because no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to product release. The physical sample involved in the reported incident was not returned for evaluation. One photo was provided by the customer. Visual evaluation of the photo was performed. The sample showed signs of use and revealed the arterial adapter (red) was disconnected from the tubing. According to the instructions for use (ifu), the customer must perform an inspection before using the device. The ifu also states to not infuse against a closed clamp or forcibly infuse a blocked catheter because backpressure could force the adapter out of the tubing. As part of the investigation process, the reported condition was analyzed, and an attempt was made to replicate it. Based on this replication of the reported condition and the instructions for use (ifu) it was confirmed that if the extension clamp was closed and a pressure was inserted, the backpressure would force the adapter out of the tubing. The reported condition has been confirmed. With the available information there is no enough evidence to relate this event with the manufacturing process. No triggers or trends were identified, and this is not a manufacturing related event, therefore, no corrective or preventive actions are required at this moment. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post-procedure, during the patient position change the arterial luer adapter detached from the line and a small crack was found on the silicone tip of the extension tube. There was no harm to the patient.
 
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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
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
jacqueline st. pierre
15 hampshire street
mansfield, MA 02048
5084524938
MDR Report Key7215128
MDR Text Key255642023
Report Number3009211636-2018-00027
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K943349
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 04/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793009
Device Catalogue Number8813793009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Yes
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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