MAUDE Adverse Event Report: BARD / C. R. BARD, INC. OG TUBE ; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND / OR INTUBATION

Model Number 0046160

Device Problem Leak/Splash (1354)

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

Event Date 12/13/2019

Event Type  malfunction  

Event Description

Pt admitted with og tube from ed.This am nurse (b)(6) noticed og leaking in between air vent pigtail.Later in the afternoon the new og tube is leaking again at the same spot.A new 16 fr is inserted.Fda safety report id# (b)(4).

• Brand Name: OG TUBE
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND / OR INTUBATION
• Manufacturer (Section D): BARD / C. R. BARD, INC.
• MDR Report Key: 9592272
• MDR Text Key: 175666167
• Report Number: MW5092243
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0046160
• Device Catalogue Number: 0046160
• Device Lot Number: NGDT3047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR