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

Model Number IPN922818

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 311375924
• Report Number: 8040412-2023-00081
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112317993
• UDI-Public: 15060112317993
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED