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

Catalog Number 105200-000020

Device Problem Material Separation (1562)

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

Event Date 08/12/2023

Event Type  malfunction  

Event Description

It was reported that "when the resident went to remove the lma, it separated and left the cuff inside the patients pharynx.Luckily the pressure tube was still attached and i was able to remove it easily".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Based on the complaint description, the product was detached during removal of the product from the patient's larynx.There was no specific or unusual condition reported during the lma removal process.Therefore, the complaint is considered as "manufacturing related" although there is no actual sample or photo of the complaint sample.An investigation was initiated to further investigate the issue.The investigation is still on-going.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.

Event Description

It was reported that "when the resident went to remove the lma, it separated and left the cuff inside the patients pharynx.Luckily the pressure tube was still attached and i was able to remove it easily".No patient harm or injury.The patient status is reported as "fine".

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17615974
• MDR Text Key: 321877554
• Report Number: 3011137372-2023-00216
• Device Sequence Number: 1
• Product Code: CAE
• 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: 08/14/2023

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 Catalogue Number: 105200-000020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 2 YR