MAUDE Adverse Event Report: GLIDERITE SINGLE-USE STYLET; STYLET, TRACHEAL TUBE

Model Number 0803-0118

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated; however, at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that during a patient procedure, using a gliderite single-use stylet, the stylet broke inside the et tube while the doctor was attempting to remove the stylet.The customer reported that the broken stylet remained in the et tube and that there was no report that any piece slipped inside the patient.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

A replacement gliderite single-use stylet was provided to the customer.The single-use stylet used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned single-use stylet and, via visual inspection, confirmed the reported damage.The technical service representative noted that the single-use stylet arrived in pieces.Since a replacement was already provided to the customer the gliderite single-use stylet used in the procedure was scrapped.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDERITE SINGLE-USE STYLET
• Type of Device: STYLET, TRACHEAL TUBE
• MDR Report Key: 11844437
• MDR Text Key: 254299431
• Report Number: 9615393-2021-00113
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0803-0118
• Device Catalogue Number: 0270-0916
• Device Lot Number: GS61119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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