MAUDE Adverse Event Report: VERATHON, CORPORATE HEADQUARTERS GLIDERITE RIGIT STYLET; STYLET GUIDE GVL PRESHAPED REUSABLE

Device Problem Break (1069)

Patient Problem Aspiration/Inhalation (1725)

Event Date 03/27/2021

Event Type  Injury  

Event Description

Blue handle / thumb tab of gliderite rigid stylet broke off during intubation of pt.Unable to retrieve metal portion of stylet from endotracheal tube.Pt had to be extubated, then reintubated.Pt vomited / aspirated between intubations.See scanned page.

• Brand Name: GLIDERITE RIGIT STYLET
• Type of Device: STYLET GUIDE GVL PRESHAPED REUSABLE
• Manufacturer (Section D): VERATHON, CORPORATE HEADQUARTERS; 20001 north creek parkway; bothell WA 98011
• MDR Report Key: 11819297
• MDR Text Key: 250842498
• Report Number: 11819297
• Device Sequence Number: 1
• Product Code: BSR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2021
• Distributor Facility Aware Date: 03/27/2021
• Device Age: 3 YR
• Event Location: Hospital
• 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 Outcome(s): Life Threatening
• Patient Age: 38 YR
• Patient Weight: 80