MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8813817009

Device Problem Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 17/apr/2017.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 prior to use on a patient the lumen was found to be obstructed.

Manufacturer Narrative

This complaint has not been confirmed.The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.A manufacturing device history record (dhr) review or product/process changes review for the involved lot number was performed.No deviations that could be related to the reported event were found.All dhrs are reviewed for accuracy prior to product release.No additional information was received for investigation.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event, however, brainstorming was performed in order to identify the possible causes for the failure.The following potential causes were identified: operator inattention, misuse, inspection failed or not performed, or defective material.No trends or triggers have been found, therefore, a corrective or 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.

Event Description

The customer states prior to use on a patient the lumen was found to be obstructed.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6497036
• MDR Text Key: 72931688
• Report Number: 3009211636-2017-05080
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1506100145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1