MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER PICC SOLO 2; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	9395108QD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Picc line attempted to left side.Difficulty with picc line advancing over to the left subclavian vein.Multiple attempts made to advance picc to svc.Upon removing line between attempts, magnet noticed to have tip broken off.Line removed, magnet tip found inside of line after line was flushed.Fda safety report id# (b)(4).

• Brand Name: POWER PICC SOLO 2
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 12525399
• Report Number: MW5104164
• Device Sequence Number: 19209419
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: 00801741035906
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 9395108QD
• Device Catalogue Number: 9395108QD
• Device Lot Number: REFS1620
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 97