MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO DL CATHETER 5F RADIOLOGY BASIC TRAY (135CM GUIDEWIRE); PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
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, at this time, for evaluation.A lot history review (lhr) of rezi1190 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that the catheter "accidentally" slipped out and was removed by the doctor.

• Brand Name: POWERPICC SOLO DL CATHETER 5F RADIOLOGY BASIC TRAY (135CM GUIDEWIRE)
• 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: 6338913
• Report Number: 3006260740-2017-00095
• Device Sequence Number: 11009097
• Product Code: LJS
• UDI-Device Identifier: 00801741028106
• UDI-Public: (01)00801741028106(17)170228(10)REZI1190
• Combination Product (Y/N): N
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

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: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 3295135
• Device Lot Number: REZI1190
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1