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

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.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,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 Key: 6649649
• MDR Text Key: 245856215
• Report Number: 3009211636-2017-05196
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• 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 Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2020
• Device Model Number: 8831661001
• Device Catalogue Number: 8831661001
• Device Lot Number: 1533000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial