• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was performed on 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 the lots manufacturing date. One used sample was received for analysis and investigation. Visual inspection was performed on the sample. The sample showed signs of use. The visual inspection of the sample revealed the arterial adapter (red) was disconnected from the tubing. The adapter and the silicone tubing were measured, and these components are inside the specifications. As part of the investigation process the reported condition was analyzed and an attempt was made to replicate it. Based on this replication and the instructions for use (ifu) it was confirmed that when the clamp is closed on the extension, backpressure would cause a force to the adapter which could make it come out of the tubing. The event reported was confirmed. An ishikawa diagram was used to determine the potential causes for this event. According to the instructions for use (ifu), the customer must perform an inspection before using the device. The ifu warns to not use the catheter if it is crushed, cracked, cut, or otherwise damaged. It also states not to infuse against a closed clamp or forcibly infuse a blocked catheter because backpressure could force the adapter out of the tubing. The reported condition occurred after that the device was in use for a period of ten days. With the available information there is not enough evidence to relate this event to the manufacturing process. The most possible cause for this event is instructions for use were not followed causing detachment of the adapter. No triggers or trends were identified, and this is 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
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 at the end of the treatment the arterial luer adapter disconnected from the extension.
 
Manufacturer Narrative
An investigation was performed. A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. In addition, all dhrs are reviewed for accuracy prior to product release. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation. No probable cause was found since no sample, picture or video were received for testing, therefore the reported condition is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. No trends or triggers have been found. Therefore, a corrective and 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states at the end of the treatment the arterial luer adapter disconnected from the extension.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 0101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6649649
MDR Text Key245856215
Report Number3009211636-2017-05196
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
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 11/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2017
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 Manufacturer08/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
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

-
-