MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH ETT, SU, SIZE 8.0

Model Number	IPN042417
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient (60 years old male) was prone for procedure with a reinforced tube in situ, no concerns on intubating, when they were moving patient from prone to supine, the airway came out of patient, causing an airway obstruction and difficulty in ventilating despite the balloon being inflated as per policy.The patient was ventilated and reintubated with another et tube, no harm came to the patient." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 "patient (60 years old male) was prone for procedure with a reinforced tube in situ, no concerns on intubating, when they were moving patient from prone to supine, the airway came out of patient, causing an airway obstruction and difficulty in ventilating despite the balloon being inflated as per policy.The patient was ventilated and reintubated with another et tube, no harm came to the patient." no patient harm or injury.The patient status is reported as "fine".

• Brand Name: LMA FASTRACH ETT, SU, SIZE 8.0
• Common Device Name: LMA FASTRACH
• 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: 17372288
• Report Number: 9681900-2023-00019
• Device Sequence Number: 7008877
• Product Code: BTR
• UDI-Device Identifier: 05060112310591
• UDI-Public: 05060112310591
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN042417
• Device Catalogue Number: 136080
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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: N/A.; N/A.
• Patient Age: 60 YR
• Patient Sex: Male