MAUDE Adverse Event Report: BARD ACCESS SYSTEM, INC. TLS STYLET

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2016

Event Type  malfunction  

Event Description

Discovered a retain foreign body in left chest during a cardiac cath (b)(6) 2016 on a pt that was not present prior to a picc line placement.A small fragment of one of the guide wires appears to be the foreign body.One guide wire was found to be intact.The copper wire was disposed of and not able to do a visual examination of it.The picc catheter was intact and usable with no problems to the pt.Pt was too ill to have the wire removed.Md opinion that any attempts to remove would results in major problems for the pt.

• Brand Name: TLS STYLET
• Type of Device: STYLET
• Manufacturer (Section D): BARD ACCESS SYSTEM, INC.; salt lake city UT 84116
• MDR Report Key: 5662250
• MDR Text Key: 45494111
• Report Number: MW5062341
• Device Sequence Number: 3
• Product Code: DRB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2016
• 3 Devices were Involved in the Event: 1 2 3

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR