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

Model Number 8888560805

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a trocar catheter.The customer stated that they tested several catheters and the trocar could not be retracted and met with resistance when being retracted.The customer reported that the needle part of one catheter broke off in the infant; a 10 fr was used and deemed successful.The customer reported no harm to the infant.

Manufacturer Narrative

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; calle 9 sur no. 125; 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: 3975379
• MDR Text Key: 18733631
• Report Number: 9612030-2014-00034
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1