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

Model Number	NBD8
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/17/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of gfav3166 showed three other similar product complaints from this lot number.
Event or Problem Description
It was reported that during preparation of insertion of the plastic stiffener, it was observed that the plastic stiffener was extremely fragile.The user tested it and the plastic stiffener broke "as glass tube" in his hands without the use of great force.No patient involvement.This file addresses the first of two devices.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a broken plastic stylet is confirmed, but the cause remains unknown.The sample returned consisted of a navarre drainage catheter label (nbd8, lot #gfav3166, expiration date 2019-09-28) and two pieces of broken plastic stylet.Visual observation found that the pieces were bent and approximately 4.1 and 5 cm long, respectively.The bends occurred in several places and the terminations appeared sharp and well-defined, which was confirmed microscopically.This breakage is characteristic of brittle failure.In addition, tactual evaluation found that one of the pieces broke at a bend when manipulated.The cause of this brittleness is unknown.This product will be sent to the manufacturing site for further review.Note that it is not evident from the two pieces of stylet whether they came from the same stylet or two different stylets.Given that the report was for two pieces and the two may have come from separate sources, the complaint is confirmed for two devices.
Event or Problem Description
It was reported that during preparation of insertion of the plastic stiffener, it was observed that the plastic stiffener was extremely fragile.The user tested it and the plastic stiffener broke "as glass tube" in his hands without the use of great force.No patient involvement.This file addresses the first of two devices.

• Brand Name: NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 8F LOCKING PIGTAIL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7246008
• Report Number: 3006260740-2018-00123
• Device Sequence Number: 11068315
• Product Code: FGE
• UDI-Device Identifier: 00801741036866
• UDI-Public: (01)00801741036866
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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 Model Number: NBD8
• Device Catalogue Number: NBD8
• Device Lot Number: GFAV3166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1