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

Model Number 8888560805

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a thoracic catheter.The customer reports the chest tube that was already implanted in the infant had to be surgically removed so a new 8fr chest tube could be re-inserted.The customer reports that there were no additional problems with the 2nd tube inserted.The customer further reports that the patient was fine.

Manufacturer Narrative

Submit date: 9/23/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reports that during the placement of the catheter, the metal trocar was stuck to the plastic tube and they were unable to remove the trocar.

Manufacturer Narrative

This information was initially provided by the customer; however, was inadvertently left of the initial report filed on (b)(6) 2014.

Manufacturer Narrative

Please see the investigation summary below: the lot number was provided and a review of the device history record (dhr) file was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.A decontaminated sample without original package or lot number was received for evaluation and the reported issue was confirmed.After reviewing the production process where the reported code is manufactured the root cause identified is the variation on the needle head diameters dimensions.Three points were measured and one of them was different.When the catheter is molding it takes the same form and variation as the diameters causing the trocar to be stuck on the catheter when the different diameters from catheter and trocar are in contact.As a corrective action, a quality alert was posted in incoming inspection to inspect (per acceptable quality level) the variation performed on the material supplied by the vendor.A quality alert will also be posted in the production line to notify appropriate personnel regarding the reported condition.The supplier was notified and they performed an improvement in their process.They have changed the bearing in all of the manual britain lathes.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: TROCAR CATH 8FR
• Type of Device: THORACIC CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 9217 3; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 9217 3; MX 92173
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4111207
• MDR Text Key: 4936682
• Report Number: 9612030-2014-00055
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888560805
• Device Catalogue Number: 8888560805
• Device Lot Number: 40300664Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other