MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGROSHONG 5F SL SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY (45CM); 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	01/06/2017
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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rear0648 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed on (b)(6) 2016, for chemotherapy.The patient was seen in the clinic on (b)(6) 2017, to disconnect the infusor bottle.It was stated that while flushing there was leaking at the site.The picc was removed in the clinic by the hcn; it was alleged that there was a crack at approximately 2cms below the external marking.Patient stated that they had not adhered to the activity restrictions at all times while the picc was in place and continued to remain active while receiving treatment, ¿possibly leading to fatigue of picc at entry to vessel.¿.

• Brand Name: POWERGROSHONG 5F SL SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY (45CM)
• 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: 6308501
• Report Number: 3006260740-2017-00046
• Device Sequence Number: 19096761
• Product Code: LJS
• UDI-Device Identifier: 00801741028533
• UDI-Public: (01)00801741028533(17)180430(10)REAR0648
• Combination Product (Y/N): N
• Initial Reporter Country: BC
• PMA/510(K) Number: K063848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2017

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: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 7818518
• Device Lot Number: REAR0648
• 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: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1