MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER & BELDAR NEEDL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx1889 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "on (b)(6) 2020 the operator involved in a picc line insertion utilizing sherlock 3cg guidance.The operator indicates that he gained vascular access, trimmed the picc and was inserting under sherlock 3cg guidance with normal tracking indicated.The operator indicates the picc appeared to be almost fully inserted when resistance was felt and sherlock tracking indicated possible ¿looping¿ of catheter.The operator flushed the picc briskly with saline and the ¿loop appeared to resolve¿.Final tip location was confirmed utilizing 3cg with max p-wave noted.Upon removal of the stylette at the end of the procedure the operator noticed a ¿kink¿ in the stylette 5 cm proximal to the nitinol stylette tip.The operator reports that the stylette was intact and the procedure was completed with the picc left in place.The operator did not retain the stylette or any other components for evaluation.".

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER & BELDAR NEEDL
• 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: 9700619
• Report Number: 3006260740-2020-00487
• Device Sequence Number: 2756044
• Product Code: LJS
• UDI-Device Identifier: 00801741154980
• UDI-Public: (01)00801741154980
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: S1193108D3
• Device Lot Number: REDX1889
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1