MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 2; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922769
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in the mri scanner we had a teleflex lma unique size 2 malfunction.The cuff completely detached from the airway tube when we pulled it, leaving the cuff inside the patient's oropharynx." the detached part was removed without incident via a finger sweep technique and a new lma was inserted and used successfully.No patient harm, injury, or desaturation.The patient status is reported as "stable, discharged home in good condition".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports the product was "detached between airway tube and backplate".A device history record review was performed and no relevant findings were identified.The complaint has been confirmed.The manufacturing site reports a capa was opened to address the issue.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "in the mri scanner we had a teleflex lma unique size 2 malfunction.The cuff completely detached from the airway tube when we pulled it, leaving the cuff inside the patient's oropharynx." the detached part was removed without incident via a finger sweep technique and a new lma was inserted and used successfully.No patient harm, injury, or desaturation.The patient status is reported as "stable, discharged home in good condition".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 2
• 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
• MDR Report Key: 17319825
• Report Number: 3011137372-2023-00180
• Device Sequence Number: 14976308
• Product Code: CAE
• UDI-Device Identifier: 15060112318150
• UDI-Public: 15060112318150
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 06/20/2023

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: 10/02/2025
• Device Model Number: IPN922769
• Device Catalogue Number: 105200-000020
• Device Lot Number: 11F22J0486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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
• Patient Sex: Unknown