MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POLY PER-Q-CATH CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9254108
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On [redacted], the patient underwent a successful picc placement.Follow-up imaging completed on [redacted] noted a 1.4 cm retained piece of guidewire.

• Brand Name: POLY PER-Q-CATH CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 20255995
• Report Number: 20255995
• Device Sequence Number: 7415311
• Product Code: LJS
• UDI-Device Identifier: 00801741035623
• UDI-Public: (01)00801741035623
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/13/2024
• Report Date (Section F): 06/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: 9254108
• Device Catalogue Number: 9254108
• Device Lot Number: REFN2073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/13/2024