MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POLY RADPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER BASIC KIT (135 CM GUIDEWIRE); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	3165135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the tip of the picc broke off in the patient during insertion while the patient was an inpatient.The health care professional assisting the physician with the procedure reported that a piece f the guidewire broke off in the patient's left arm and was not retrieved and the device was not placed.They also state that patient was notified.It was reported that the patient came back to the facility for x-rays/ultrasound on (b)(6) 2017 and the device was not retrieved.

• Brand Name: POLY RADPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER BASIC KIT (135 CM 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: 7396158
• Report Number: 3006260740-2018-00586
• Device Sequence Number: 11081085
• Product Code: LJS
• UDI-Device Identifier: 00801741034954
• UDI-Public: (01)00801741034954
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K034019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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 Model Number: 3165135
• Device Catalogue Number: 3165135
• 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: 04/04/2018
• 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: Other