MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4

Model Number	IPN047898
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.
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.
Additional Manufacturer Narrative
(b)(6).The sample was returned and sent to the manufacturing site for evaluation.The manufacturer reports: "complaint sample received and visual inspection was performed on the product.When reviewing on the inflation line to cuff pressure valve (cpv) joint, tear was found at the area.Leak test was performed to the complaint sample.Presence of air bubble was identified when it was immersed in the water.The leak was found at the tear line to cpv area.Dhr was reviewed.No abnormality was found.This lot was manufactured on (b)(6) 2018 and will have been expired on (b)(6) 2021.This complaint sample passed all the necessary inspections based on dhr and the reason as to return sample show tear at the joint of inflation line and cpv could not be determined.The end user was using the expired product while it had already been expired since nov 2021; the product was considered misused by the user.".

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• 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: 13446420
• Report Number: 9681900-2022-00005
• Device Sequence Number: 14533492
• Product Code: CAE
• UDI-Device Identifier: 05060112313868
• UDI-Public: 05060112313868
• 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 Expiration Date: 11/28/2021
• Device Model Number: IPN047898
• Device Catalogue Number: 192040
• Device Lot Number: NMCRZ5
• 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