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	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "it was found before using it to the patient.There was air leaking at the cuff pilot".No patient involvement reported.
Event or Problem Description
It was reported that "it was found before using it to the patient.There was air leaking at the cuff pilot".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturer reports: "visual inspection performed on the complaint sample.No abnormality found on the product from its outer profile.Leak test was performed to the complaint sample.Presence of bubble was identified on the tear location.The leak was found at the cuff sealing and side flap and backplate area.Functional test was performed on complaint sample.Cuff could not maintain the deflation and inflation due to leak.Dhr was reviewed.There was no abnormality found.Based on the complaint description, the complaint is related to leak air from cuff pilot prior to use.Visual inspection on the sample received has found no abnormality.Functional test on the complaint sample has shown present of bubbles (leak on cuff).Leak test was performed on the complaints sample and present of bubbles (leak) on the cuff was observed.Deflation and inflation test was performed on the product, the cuff could not maintain the pressure due to leak area.In conclusion, the root cause of the failure was manufacturing related complaint." a non-conformance was opened to further address this issue.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• Common Device Name: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11641791
• Report Number: 9681900-2021-00008
• Device Sequence Number: 2999372
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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
• Operator of Device: No Information
• Device Expiration Date: 12/28/2022
• Device Model Number: IPN047898
• Device Catalogue Number: 192040
• Device Lot Number: PMDFYD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1