MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922772
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device investigation is pending and the results will be submitted in a follow-up report.
Event or Problem Description
Reported issue: string of plastic was noticed inside the patient's mouth after the lma was inserted.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one opened representative sample along with two un-opened representative samples for evaluation.The actual device used in the event was not returned.The manufacturing site reports that the opened sample was visually inspected and did not show the printing trimmed off as reported in the complaint and as seen in the photos provided by the customer.A device history record review was performed on the lot number reported and no relevant findings were identified.The manufacturing site reports "based on the review of the dhr and non-conformance (nc) list, there is no record of printing peeled off or part of airway tube were skimmed/trimmed off.The type of defect is not originated from any of the in house assembly process." 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
Reported issue: string of plastic was noticed inside the patient's mouth after the lma was inserted.No patient injury/consequence or medical intervention reported.The patient condition was reported as "fine".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16550086
• Report Number: 9681900-2023-00008
• Device Sequence Number: 6042452
• Product Code: CAE
• UDI-Device Identifier: 15060112318181
• UDI-Public: 15060112318181
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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 Expiration Date: 08/18/2025
• Device Model Number: IPN922772
• Device Catalogue Number: 105200-000040
• Device Lot Number: 11F22H0316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown