MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 8F LOCKING PIGTAIL; PATIENT CARE SUCTION APPARATUS

Catalog Number NOD8LPT

Device Problems Suction Problem (2170); Aspiration Issue (2883)

Patient Problems No Consequences Or Impact To Patient (2199); 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 one day after pericardial drainage, there was a blockage of the tube.When the drainage tube was flushed in an effort to clear the blockage, it was discovered that the connector was cracked.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one navarre locking pigtail 8 fr opti drainage catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.The investigation is inconclusive for being unable to aspirate, as the device was patent to infusion and aspiration; no leaks were observed.Although, it is unknown if a clinical procedure caused the catheter unable to aspirate.The definitive root cause could not be determined as there were no apparent problems with the device with respect to catheter patency.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 one day after pericardial drainage, there was a blockage of the tube.When the drainage tube was flushed in an effort to clear the blockage, it was discovered that the connector was cracked.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 8F LOCKING PIGTAIL
• Type of Device: PATIENT CARE SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7659625
• MDR Text Key: 113067607
• Report Number: 3006260740-2018-01596
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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: 06/26/2018
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1