MAUDE Adverse Event Report: TELEFLEX MEDICAL TRULITE SECURE SU BLADE-HANDLE MILL 0; LARYNGOSCOPE, RIGID

Catalog Number	004670000
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the pediatric patient was being intubated for respiratory insufficiency following delivery.The appropriate size laryngoscope blade for the size patient was selected 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 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.There was no other reported patient consequence from the incident.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the pediatric patient was being intubated for respiratory insufficiency following delivery.The appropriate size laryngoscope blade for the size patient was selected 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 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.There was no other reported patient consequence from the incident.

• Brand Name: TRULITE SECURE SU BLADE-HANDLE MILL 0
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19211513
• Report Number: 8030121-2024-00007
• Device Sequence Number: 20558913
• Product Code: CCW
• UDI-Device Identifier: 14026704626141
• UDI-Public: 14026704626141
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 004670000
• Device Lot Number: 230318601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown