MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 8F LOCKING PIGTAIL; CATHETER, IRRIGATION

Catalog Number NNU8LPT

Device Problem Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

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 the pigtail was defective and the inner stylet couldn't be inserted into the pigtail as it was kinked.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: per the lot history review, this is the first complaint reported for this lot number and issue to date.The quantity affected is one.Based upon the severity level and lot quantity, a dhr review is not required per (b)(4).Based on the manufacturing site: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the evaluation: one navarre locking pigtail 8 fr percutaneous biliary drainage catheter was returned for evaluation.Visual and functional evaluations were performed.The original cannula was not returned with the catheter sample so the investigation is inconclusive for the inner stylet not being able to be inserted into the pigtail, as the device functioned properly under laboratory conditions and the reported event could not be reproduced.The root cause for the inner stylet not being able to be inserted into the pigtail is inconclusive as the returned catheter had no apparent defects and functioned properly when interfaced with non-original samples.The original cannula sample was not returned.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.The information provided by bd 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 bd.

Event Description

It was reported that the pigtail was defective and the inner stylet couldn¿t be inserted into the pigtail as it was kinked.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 8F LOCKING PIGTAIL
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7683258
• MDR Text Key: 113875231
• Report Number: 3006260740-2018-01709
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741037009
• UDI-Public: (01)00801741037009
• Combination Product (y/n): N
• PMA/PMN Number: K951907
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NNU8LPT
• Device Lot Number: GFBT1231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 79