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 gfbs1859 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (gfbs1859) have been reported from the same facility.
Event or Problem Description
It was reported that prior to using the device, during preparation of the drain (insertion of the plastic stiffener into the drain) it was observed that the plastic stiffener was extremely fragile.The user experienced low elasticity of the plastic stiffener.He tested it and the plastic stiffener broke ¿as glass tube¿ in his hands without the use of great force.He tried another one from the same lot with the same result.Another device was used to complete the procedure successfully.There was no patient involvement.This file addresses the first of five 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/brittle stylet is confirmed for each of the 5 samples, but the cause is unknown.The devices returned were five navarre drainage catheters in their pouches, one of the pouches being opened (sample 1).In each case, the catheter, cap, and stylet were present in the pouch.In sample 1, the stylet was found to be broken in two pieces inside the open pouch.Both ends of the distal end of the broken stylet were fractured, and so it appears that some of the stylet tube is missing.No obvious damage was noted visually on the other devices.In samples 2-5, the stylet was curled into a circle, inserted fully into the catheter, and then a thumb was run across the stylet distally while inducing a small angle in the stylet.In each of these samples, the stylet broke during this third step.In each sample, the stylet break(s) appeared well-defined and sharp, typical of brittle failure.The cause of this brittleness is unknown.This product will be sent to the manufacturing site for further review.A lot history review (lhr) of gfbs1859 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (gfbs1859) have been reported from the same facility.
Event or Problem Description
It was reported that prior to using the device, during preparation of the drain (insertion of the plastic stiffener into the drain) it was observed that the plastic stiffener was extremely fragile.The user experienced low elasticity of the plastic stiffener.He tested it and the plastic stiffener broke ¿as glass tube¿ in his hands without the use of great force.He tried another one from the same lot with the same result.Another device was used to complete the procedure successfully.There was no patient involvement.This file addresses the first of five 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: 7249050
• Report Number: 3006260740-2018-00147
• Device Sequence Number: 19135620
• 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): 04/06/2018

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: GFBS1859
• 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: 03/19/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1