MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH ETT 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN042399
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the [doctor], did an awake intubation yesterday, and after placing the tube, the injection port on the pilot tube to the cuff, was found to have a defect".It further states that "we are using these as single use (since the disposable version was discontinued) but they arrive in packaging that says 'autoclave before use', so they have all been sent to be sterilized before use".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.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The actual sample, along with a representative sample, was returned and sent to the manufacturing site for investigation.The manufacturing site reports "actual sample was received for investigation.The pilot balloon on the check valve area was tear.Based on manufacturing process, all devices are inspected, and reviewed, at multiple points and shall be detected during inspection.Furthermore, the information from complaint that the defect was identified after autoclaving.Potential this would be happen during this process.Reprocessing is critical to the usage and properties of the device, no matter temperature settings, holding time or washing agents or add on reprocessing i washing i brushing measures on the device.Additionally, as per instruction of use (/fu), careful handling is essential.The device is made of medical-grade silicone which can be torn or perforated.Avoid contact with sharp or pointed objects at all times.".
Event or Problem Description
It was reported that "the [doctor], did an awake intubation yesterday, and after placing the tube, the injection port on the pilot tube to the cuff, was found to have a defect".It further states that "we are using these as single use (since the disposable version was discontinued) but they arrive in packaging that says 'autoclave before use', so they have all been sent to be sterilized before use".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: LMA FASTRACH ETT 7.0MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• 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: 16924148
• Report Number: 9681900-2023-00015
• Device Sequence Number: 20591310
• Product Code: BTR
• UDI-Device Identifier: 15060112318778
• UDI-Public: 15060112318778
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K991580
• 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): 04/21/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN042399
• Device Catalogue Number: 131070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown