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	02/13/2018
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 gfbs1249 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during preparation of insertion of the plastic stiffener, the user observed that the plastic stiffener was extremely fragile.The user tested the plastic stiffener before usage and it broke "as glass tube" in his hands without the use of great force.No patient involvement.
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 not determined.One open package with product code nbd8 and lot #gfbs1249 was returned for investigation.A broken stylet was found within the package.Three larger segments of stylet were found in the package.The proximal segment, which contained the white hub, was 14.5 cm in length.A second segment was 23cm in length.A third segment was 11.5cm in length.Four smaller fragments of the stylet were also found in the package.The smallest segment was 1.5mm x 1.0mm x 0.5mm.The fractured ends of the stylet segments had jagged edges.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.¿ the complaint sample was forwarded to the manufacturing facility for further review.A lot history review (lhr) of gfbs1249 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during preparation of insertion of the plastic stiffener, the user observed that the plastic stiffener was extremely fragile.The user tested the plastic stiffener before usage and it broke "as glass tube" in his hands without the use of great force.No patient involvement.

• 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: 7318007
• Report Number: 3006260740-2018-00370
• Device Sequence Number: 151268
• 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): 05/02/2018

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: 05/28/2020
• Device Model Number: NBD8
• Device Catalogue Number: NBD8
• Device Lot Number: GFBS1249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1