MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F MA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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 reds4277 showed no other similar product complaint(s) from this lot number.Mw5090812.
Event or Problem Description
It was reported per medwatch, "pt had picc line placed.After placement it was noted that a fragment of guidewire had broken off.".

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F MA
• 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: 9700617
• Report Number: 3006260740-2020-00483
• Device Sequence Number: 2824863
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020
• Report Date (Section F): 10/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 9395108QD
• Device Lot Number: REDS4277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• 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
• Date Report Sent to FDA: 10/26/2019