MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK XS; TROCAR

Catalog Number G407211

Device Problems Bent (1059); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2017

Event Type  malfunction  

Event Description

Upon removal of stylet from the needle, staff noticed resistance from the stylet.Staff also noticed the stylet was bent on the back end.Upon removal of the entire stylet she noticed it was bent at the back-end.Upon removal of the entire stylet she noticed it was bent at the tip.The needle never entered the patient's body and there was no harm to the patient.

• Brand Name: BRK XS
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau pl.; minnetonka MN 55345
• MDR Report Key: 6442201
• MDR Text Key: 71137488
• Report Number: 6442201
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: G407211
• Device Lot Number: 5665743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR