MAUDE Adverse Event Report: COVIDIEN TROCAR CATH 8FR; TROCAR CATHETER

Model Number 8888560805

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a trocar catheter.The customer states that the cap of the stylet fell off.The product was used on a pt, the procedure went fine, and there was no medical intervention required to the pt as a result of this incident.

Manufacturer Narrative

A review of the device history record (dhr) confirms no deviations occurred during the production of lot number 12i126fhx.One unused sample that was not the actual complaint sample was returned to the manufacturing facility.As the sample returned was not the complaint sample the reported condition could not be confirmed.Based on the complaint description, the blue ball disconnected from the trocar rod.The actual root cause of this complaint could not be determined.However, during the assembly process a hole is drilled into the ball and the rod is then inserted into the hole.The rod and ball remain assembled via an interference fit as the rod diameter is larger than the hole drilled in the blue ball diameter.The most probable root cause identified is that there was inadequate interference between the rod and ball.Procedures have been initiated to identify possible reasons for rod + ball disconnect and implement improvements to the assembly process.During manufacturing the ball is 100% tested for interference fit once assembled to the rod as per procedure.A quality alert was initiated and manufacturing was trained to make them aware of the reported issue and to ensure that 100% testing is being completed.This complaint will also be used for tracking and trending purposes.

Manufacturer Narrative

Submit date on: 09/16/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: TROCAR CATH 8FR
• Type of Device: TROCAR CATHETER
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; tullamore, co. offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4232405
• MDR Text Key: 4975975
• Report Number: 9611018-2014-00004
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888560805
• Device Catalogue Number: 8888560805
• Device Lot Number: 12I126FHX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 09/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1