MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN TRI-FUNNEL; GASTROINTESTINAL TUBE AND ACCESSORIES

Catalog Number UNKNOWN

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported to medical services, nurse practitioner reports difficulty with deflating tri-funnel replacement tubes and reports seeing what looks like crystallizations in the fluid when it¿s removed from the balloon.Nurse confirmed the balloon was in place for 8 weeks when she tried to deflate.The tubes were placed in the radiology department, so a mixture of contrast and saline was used to inflate the balloon and confirm placement.Ifu states water or saline should be used to fill the balloon and for optimal performance, the bard tri-funnel tube should be replaced every 30 days or as required to ensure balloon patency and an un-occluded tube lumen.This file addresses the second tri-funnel replacement.

• Brand Name: UNKNOWN TRI-FUNNEL
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6506097
• MDR Text Key: 73516105
• Report Number: 3006260740-2017-00460
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1