MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 8F LOCKING PIGTAIL; PATIENT CARE SUCTION APPARATUS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
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 gfav3164 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after checking with the nurse, the staff was preparing for a ptc procedure and attempted to thread the plastic stylet into the catheter.It was stated before she could thread the plastic stylet in, the hub of the stylet broke from the main body of the plastic stylet.Another new set had to be opened to complete the procedure.Original device was not used on the patient.

• Brand Name: NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 8F LOCKING PIGTAIL
• Common Device Name: PATIENT CARE SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6974786
• Report Number: 3006260740-2017-01890
• Device Sequence Number: 1975149
• Product Code: FGE
• UDI-Device Identifier: 00801741036866
• UDI-Public: (01)00801741036866
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: 09/01/2019
• Device Model Number: N/A
• Device Catalogue Number: NBD8
• Device Lot Number: GFAV3164
• 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: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1