MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH ETT, SU, SIZE 7.0; AIRWAY, OROPHARYNGEAL, ANESTHE

Model Number	IPN042415
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the customer indicates that the fastrach tube could not be inserted well through the fastrach laryngeal mask, but this was solved by turning the tube 15 degrees".No patient injury or harm reported.Patient condition unknown at time of report.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the customer indicates that the fastrach tube could not be inserted well through the fastrach laryngeal mask, but this was solved by turning the tube 15 degrees".No patient injury or harm reported.Patient condition unknown at time of report.
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.The customer did not provide a lot number; therefore, a device history record review was performed based upon a potential lot number reported by the sales rep.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 customer indicates that the fastrach tube could not be inserted well through the fastrach laryngeal mask, but this was solved by turning the tube 15 [degrees]".No patient injury or harm reported.Patient condition unknown at time of report.

• Brand Name: LMA FASTRACH ETT, SU, SIZE 7.0
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13197934
• Report Number: 9681900-2021-00053
• Device Sequence Number: 6046243
• Product Code: BTR
• UDI-Device Identifier: 05060112310577
• UDI-Public: 05060112310577
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K051993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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 Model Number: IPN042415
• Device Catalogue Number: 136070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/14/2022
• 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
• Patient Sex: Unknown