MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 8F LOCKING PIGTAIL; CATHETER, BILIARY, DIAGNOSTIC

Model Number NBD8

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.

Event Description

It was reported that during the procedure the stylet broke.It was further reported that the physician was using the stylet as a support.The procedure was completed without incident.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was required.The lot met all release criteria.Investigation summary: the device returned was one plastic navarre stylet.Four photographs were also returned, two of labeling and two of stylet piece(s).These photographs as a whole confirmed the product number to be nbd8 and the lot to be gfat2516.The breakage of the stylet into at least three pieces was confirmed from the photographs, as well as red and tan residues within the lumens.Visual observation found the stylet broken into 6 pieces, one with the luer attached.The pieces manifested residues.In several pieces, further bends were found which had not yet resulted in full breaks.Microscopic evaluation found the breaks to consist of partially brittle fractures, with significant evidence of bending and whitening juxtaposed.The two longest fully detached pieces were bent and found to fracture in a brittle manner.The complaint of a broken navarre stylet is confirmed.The brittleness of the stylet is related to the breakage of the stylet.The definitive root cause for the reported brittleness/breakage issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

Event Description

It was reported that during the procedure the stylet broke.It was further reported that the physician was using the stylet as a support.The procedure was completed without incident.There was no reported patient injury.

• Brand Name: NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 8F LOCKING PIGTAIL
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7493110
• MDR Text Key: 107571006
• Report Number: 2020394-2018-00595
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00801741036866
• UDI-Public: (01)00801741036866
• Combination Product (y/n): N
• PMA/PMN Number: K955110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: NBD8
• Device Catalogue Number: NBD8
• Device Lot Number: GFAT2516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1