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

Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: STYLET
• Manufacturer (Section D): BARD ACCESS SYSTEM, INC.; salt lake city UT 84116
• MDR Report Key: 5662250
• Report Number: MW5062341
• Device Sequence Number: 10837544
• Product Code: DRB
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR