MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLEE SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 110050

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Unintended Extubation (4564)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported that:"after changing a flexible lma # 5 to a tube during ent surgery, anaesthetist noticed a small piece of silicone inside the patients mouth, that matched a missing part of the lma.Flexible lma # 5 was inserted into the patient and then taken out." additional information reported that the patient current condition is fine.

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that:"after changing a flexible lma # 5 to a tube during ent surgery, anaesthetist noticed a small piece of silicone inside the patients mouth, that matched a missing part of the lma.Flexible lma # 5 was inserted into the patient and then taken out." additional information reported that the patient current condition is fine.

Manufacturer Narrative

(b)(4).The sample was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports "the glue line at joint between cuff and backplate was observed damage upon receipt.When visually inspected, there was glue stains / marks at joint on the cuff.Dhr was reviewed.No abnormality was found." the complaint is confirmed.The device was manufactured in 2018.There was no use record card listing the date of initial use of the device until its last use.The autoclave parameters such as temperature, holding time and washing agents used during autoclave were unknown.It is also important to have the relevant information such as reprocessing parameters, washing agents involved, number of uses undergone and invoice information of the complaint sample for investigation.The root cause of the incident is classified as undetermined.

• Brand Name: LMA FLEXIBLEE SIZE 5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14994807
• MDR Text Key: 296615456
• Report Number: 9681900-2022-00025
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 110050
• Device Lot Number: 9FUAAASY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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