MAUDE Adverse Event Report: TELEFLEX MEDICAL BLADE RUSCH MAC 4; LARYNGOSCOPE, RIGID

Catalog Number 670150-100040

Device Problem Material Fragmentation (1261)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that "during a laryngoscopy, the plastic part of the blade broke in use".As a result there was "lower lip bleeding and delay in intubation.The blade was changed".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be completed as no lot number was provided.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.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "it is revealed that the heel of the foot part has broken due to improper engagement of the blades on handle.The end user has not engaged blade properly onto the handle and apply unnecessary force in the form of jerk which resulted in breakage of front lip of heel.If the heel had been broken due to application of load then, engagement lock must have broken but it is still there which shows that the blade was not properly engaged." the complaint has been confirmed and the root cause is determined to be user related.

Event Description

It was reported that "during a laryngoscopy, the plastic part of the blade broke in use".As a result there was "lower lip bleeding and delay in intubation.The blade was changed".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: BLADE RUSCH MAC 4
• Type of Device: 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: 16961547
• MDR Text Key: 315654235
• Report Number: 8030121-2023-00015
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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: Health Professional
• Device Catalogue Number: 670150-100040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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