MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu0635 showed no other similar product complaint(s) from this lot number.Mw5092840.
Event or Problem Description
It was reported via medwatch "insertion wire noted on imaging.Vendor safety strategies to prevent inadvertent shearing during insertion.Consider coloring the tip of the guidewire and the stylet a different color each (not red) this will assist the prodecuralist in determining if the entire wire has been withdrawn).¿.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9826242
• Report Number: 3006260740-2020-00846
• Device Sequence Number: 3086617
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2020
• Report Date (Section F): 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 9295108D
• Device Lot Number: REDU0635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/12/2020
• 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: Required Intervention
• Date Report Sent to FDA: 02/04/2020