MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9295108D
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rezj0993 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
On (b)(6) 2016 - per medwatch form, "retained piece of catheter.Dates of use: (b)(6) 2016.Diagnosis or reason for use: picc line for chemotherapy." on (b)(6) 2016 - nurse from facility reported that their team investigated this case and found that there were no issues in the product (picc line).Nurse stated it was an operator error.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5632686
• Report Number: 3006260740-2016-00210
• Device Sequence Number: 10798673
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760(17)170428(10)REZJ0993
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2016
• Report Date (Section F): 02/29/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2017
• Device Catalogue Number: 9295108D
• Device Lot Number: REZJ0993
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2016
• 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: Disability
• Date Report Sent to FDA: 02/29/2016