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	08/31/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of gfav3665 shows eleven other similar product complaint(s) from this lot number.The complaints for this lot number (gfav3665) have been reported from the same facility.
Event or Problem Description
The plastic fixator of all the units from the indicated batch number breaks easily.The issue was found at the distributor facility.No patient involvement.This file addresses device #10.
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 damaged stylet was confirmed but the exact cause was unknown.Ten navarre drainage catheter kits were returned for investigation.One kit was open and nine kits were sealed.Contained in the open kit (sample #1) was a broken flexible stylet.The injection cap was attached to the stylet luer adaptor.There was a break in the stylet at the distal end of the white connector and 1.3cm from the distal end of the white connector.The stylet was kinked 1.1cm distal to the break.The sealed packages were labeled samples #2 - #10.The stylet for sample #2 was kinked approximately 2cm and 4cm distal to the white connector.Sample #3 exhibited a kink 1.4cm from the white connector and a break 2.5cm from the white connector.Sample #4 exhibited a break 1.5cm from the distal end of the white connector.Sample #5 exhibited a break 1.0cm from the distal end of the white connector.No breaks were observed on samples #6, #7, #8, #9, & #10.Sample #8 was opened for additional investigation.The clear portion of the stylet extended approximately 18.5cm from the distal end of the label and approximately 8.7cm from the proximal end of the label.The stylet was removed and flexed 4.5cm, 18.5cm, & 41.5cm from the distal end of the white connector.The stylet snapped and fractured at each flex point.A microscopic examination of the fractured ends of the stylet revealed jagged edges.The complaint samples were forwarded to the manufacturing facility for further review.A review of the manufacturing records showed no potential contributing factors to the stylet damage.The product ifu cautions, ¿do not use excessive force when inserting stiffening cannula to straighten catheter (pigtail).Catheter tip may be straightened manually to aid in insertion of stiffening cannula.¿ a lot history review (lhr) of gfav3665 shows eleven other similar product complaint(s) from this lot number.The complaints for this lot number (gfav3665) have been reported from the same facility.
Event or Problem Description
The plastic fixator of all the units from the indicated batch number breaks easily.The issue was found at the distributor facility.No patient involvement.This file addresses device #10.

• 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: 6886463
• Report Number: 3006260740-2017-01682
• Device Sequence Number: 10787894
• Product Code: FGE
• UDI-Device Identifier: 00801741036866
• UDI-Public: (01)00801741036866
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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 Expiration Date: 09/28/2019
• Device Model Number: NBD8
• Device Catalogue Number: NBD8
• Device Lot Number: GFAV3665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1