MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER PICC SOLO CATHETER WITH SHERLOC TIP LOCATION SYSTEM STYLET; CATHETER, INTRAVASCULAR, THERAPEUTIC LONG TERM

Model Number	9395108QD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc line magnet broken on the tip of guidewire when removed from catheter after placement.A second radiograph was included of a picc line that was attempted to be placed.A short segment of metallic wire is seen in the distal tip of the catheter measuring 4.3 cm in length, possibly a portion of the guideline what was reportedly broken.The picc line was removed and replaced with a bard power picc solo catheter.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
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 9192845
• Report Number: MW5090377
• Device Sequence Number: 16255387
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 10/31/2020
• Device Model Number: 9395108QD
• Device Catalogue Number: 9395108QD
• Device Lot Number: REDS4277
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• 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: Required Intervention
• Patient Age: 86 YR