MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	100040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: laryngeal mask '4 is opened and the balloon is observed broken.The issue was identified prior to use.There was no patient involved.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was reported.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
It was reported that: laryngeal mask '4 is opened and the balloon is observed broken.The issue was identified prior to use.There was no patient involved.

• Brand Name: LMA CLASSIC SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18451324
• Report Number: 3009307931-2024-00002
• Device Sequence Number: 7780793
• Product Code: CAE
• UDI-Device Identifier: 04026704397617
• UDI-Public: 04026704397617
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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 Catalogue Number: 100040
• Device Lot Number: RFABDY
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown