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

Model Number	IPN922818
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The complaint sample was received.The size and lot number were the same as the complaint description.The part from the device that detached during the procedure also was returned for investigation.On review of the device, it was noted that there was not excess glue that detached from the device because the color was different.Glue was clear colored, but the detached part was light blue.The excess glue was hard to detach from the cuff with the clear color.Additional testing was performed by comparing the detached part with the airway tube.Visual inspection was performed, the material condition and color were the same as the airway tube.The round shape of the part potentially from the airway tube area.The root cause is that both areas, backplate distal end and drain tube to backplate gluing area have the presence of the glue on the jointing area but there was no clear evidence that an excess glue was detached from both areas.Furthermore, the foreign part or small plastic ring as per the complaint description was not available with the complaint sample to further investigate.Based on the review results of the two complaints, one was manufacturing related, and one is undetermined.The device history review found no abnormality related to the tube foreign matter/flashing.Further investigation will be carried out through nonconformance.
Event or Problem Description
Reported issue: a ring came loose and got inside the patient.On the recovery the patient coughs it up.No harm or intervention for the patient.

• 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 (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16550943
• Report Number: 8040412-2023-00081
• Device Sequence Number: 20070491
• Product Code: CAE
• UDI-Device Identifier: 15060112317993
• UDI-Public: 15060112317993
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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: 03/01/2025
• Device Model Number: IPN922818
• Device Catalogue Number: 192050
• Device Lot Number: 11F22C0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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
• Patient Sex: Unknown