MAUDE Adverse Event Report: C. R. BARD, INC. POWER PICC SOLO CATHETER WITH SHERLOC TIP LOCATION SYSTEM STYLET; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	9395108QD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Difficulty placing picc line on patient.Upon removing wire discovered the magnet was broken off.Chest xray order and physician an manager notified.Broken part of the wire with magnet was found in the patient right lower lobe of the lung.Fda safety report id# (b)(4).

• Brand Name: POWER PICC SOLO CATHETER WITH SHERLOC TIP LOCATION SYSTEM STYLET
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 10605816
• Report Number: MW5096945
• Device Sequence Number: 2578264
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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 Expiration Date: 10/31/2021
• Device Model Number: 9395108QD
• Device Catalogue Number: 9395108QD
• Device Lot Number: REES3287
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2020
• 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: 43 YR