MAUDE Adverse Event Report: HALYARD HALYARD; G-TUBE

Catalog Number 0100-24

Device Problems Break (1069); Split (2537)

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

Event Date 10/27/2017

Event Type  malfunction  

Event Description

When inflating balloon on g-tube it ripped.A second tube was pulled and it also ripped during inflation.A 3rd g-tube was pulled and the shaft split between the ring and the balloon.A 4th g-tube was pulled and inserted without incident.

• Brand Name: HALYARD
• Type of Device: G-TUBE
• Manufacturer (Section D): HALYARD
• MDR Report Key: 7037452
• MDR Text Key: 92475617
• Report Number: MW5073355
• Device Sequence Number: 1
• Product Code: PIF
• 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: 11/14/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 0100-24
• Device Lot Number: AA6306D17
• Was Device Available for Evaluation?: Yes
• 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