MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH; LARYNGOSCOPE, RIGID

Catalog Number 004670000

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

The pediatric patient was being intubated for respiratory insufficiency following delivery.The appropriate size laryngoscope blade for the size patient was selected (rusch trulite 0 blade) for the procedure.Neonate nurse practitioner (nnp) attempted airway placement and was unable to gain view due to size and width of blade.Upon withdrawal of the laryngoscope from the mouth, the patients gums received a small abrasion and subsequent bleeding from the bare metal edges of the laryngoscope.The rusch handle that caused the abrasion is much wider than others and does not have a safety coating on the blade.Because of the device issues, there were increased attempts at intubation and abrasion to tissues.Provider felt that the design of laryngoscope blade-too wide, rough edges, and protruding light housing.Manufacturer response for laryngoscope handle blade combination, trulite secure laryngoscope handle blade combination (per site reporter).No response to date.

• Brand Name: RUSCH
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 19011128
• MDR Text Key: 339006942
• Report Number: 19011128
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 004670000
• Device Lot Number: 230318601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other