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

Model Number IPN922769

Device Problem Break (1069)

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

Event Date 06/20/2023

Event Type  malfunction  

Event 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".

Manufacturer Narrative

(b)(4).

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 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
• Type of Device: 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
• MDR Text Key: 318980988
• Report Number: 3011137372-2023-00180
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318150
• UDI-Public: 15060112318150
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1