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 Information (3190)

Event Date 06/22/2017

Event Type  malfunction  

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.

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.

• 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 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 Key: 6887850
• MDR Text Key: 87609775
• Report Number: 3009211636-2017-05306
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521005235
• UDI-Public: 10884521005235
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• 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
• Patient Sequence Number: 1