MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 8F LOCKING PIGTAIL; CATHETER, IRRIGATION

Catalog Number NOD8LPT

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

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.There was no reported patient injury.

Event Description

It was reported that the pigtail was defective and the inner stylet couldn¿t be inserted into the pigtail.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria 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.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.

• Brand Name: NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 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: 7679424
• MDR Text Key: 113746310
• Report Number: 3006260740-2018-01686
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741037092
• UDI-Public: (01)00801741037092
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/28/2019

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 Catalogue Number: NOD8LPT
• Device Lot Number: GFBW1535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 02/26/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 80