MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 5

Model Number	IPN922818
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "cuff leak was found before using, the patient, the pressure cannot be controlled, and the pressure was decreased".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "cuff leak was found before using, the patient, the pressure cannot be controlled, and the pressure was decreased".No patient involvement reported.
Event or Problem Description
It was reported that "cuff [leak] was found before using the patient, the pressure cannot be controlled, and the pressure was decreased".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The actual sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the complaint sample was received.The outer profile of the product was standard and normal.Leak test was performed to the complaint sample.Presence of bubble was identified when it was immersed in the water.The leak was found at the cuff sealing & side flap and backplate area." the customer did not provide a lot number; therefore, a device history record review was performed based upon a potential lot number (pmcxju).No relevant findings were identified.The manufacturing site reports the root cause of the failure was manufacturing related.A non-conformance was opened to address the issue.The lot was manufactured prior to the corrective action.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 5
• Common Device Name: LMA PROTECTOR
• 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: 13446468
• Report Number: 9681900-2022-00004
• Device Sequence Number: 14533497
• Product Code: CAE
• UDI-Device Identifier: 15060112317993
• UDI-Public: 15060112317993
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: IPN922818
• Device Catalogue Number: 192050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/28/2022
• 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
• Patient Sex: Unknown