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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 8831661001
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 06/22/2017
Event Type  malfunction  
Manufacturer Narrative
Through additional information received it was confirmed this event is not associated with regulatory report 3009211636-2017-05196. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states, at the end of treatment, the device disconnected at the extensions. Patient outcome is unknown.
 
Manufacturer Narrative
A device history record (dhr) review was performed to the reported lot. No discrepancies that may have contributed to a complaint of this nature were found. All dhrs are reviewed for accuracy prior to product release. No changes related to the reported condition were found within six months prior to lots manufacturing date. One used sample was received analysis and investigation. The visual inspection of the sample revealed the arterial adapter (red) was disconnected from tubing. The adapter and the silicone tubing were measured, and the components were inside the specifications. As part of the investigation process the reported condition was analyzed and an attempt to replicate it was made. Based on this replication and the instructions for use (ifu) it was confirmed that if the extension clamp was closed, and pressure was increased, backpressure would cause force to the adapter and it could come out of the tubing. An ishikawa diagram was used to determine the potential causes for this event. Based on the event description the catheter was in use for a period of ten days, this is evidence that the adapter was placed properly. According to the instructions for use (ifu), the customer should perform an inspection before using the device. The ifu states to not use the catheter if it is crushed, cracked, cut, or otherwise damaged and not to infuse against a closed clamp or forcibly infuse a blocked catheter. The reported condition has been confirmed. With the available information there is not enough evidence to relate this event with the manufacturing process. The most possible cause for this event is the instructions for use were not followed. No harm was reported, no triggers or trends were identified, and this was not a manufacturing related event, therefore no corrective and preventive action (capa) is required at this moment. It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This event could be associated with regulatory report 3009211636-2017-05196. Good faith efforts are underway to get additional information regarding the event and patient outcome. This report is being filed based on a second device being received. When additional information is obtained a follow-up report will be submitted. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states, at the end of treatment, the device disconnected at the extensions. Patient outcome is unknown.
 
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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
diane matheus
15 hampshire street
mansfield, MA 02048
5085421480
MDR Report Key6887850
MDR Text Key195667190
Report Number3009211636-2017-05306
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 12/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
Device Model Number8831661001
Device Catalogue Number8831661001
Device Lot Number1533000125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2015
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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