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

Catalog Number 110040

Device Problem Inflation Problem (1310)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Complaint reports that: the device is not staying inflated when used on the patient.The event was detected during use on patient.No patient injury/consequence or medical intervention reported.The case went fine and patient doing well.

Manufacturer Narrative

Qn #(b)(4).

Event Description

Complaint reports that: the device is not staying inflated when used on the patient.The event was detected during use on patient.No patient injury/consequence or medical intervention reported.The case went fine and patient doing well.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Manufacturer Narrative

(b)(4).The sample was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports that a visual exam was performed and no issues were observed.The device was then immersed in water and no air bubbles were observed coming from the device, indicating no leakage at the cuff and joint area.It was also reported that a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Complaint reports that: the device is not staying inflated when used on the patient.The event was detected during use on patient.No patient injury/consequence or medical intervention reported.The case went fine and patient doing well.

• Brand Name: LMA FLEXIBLE SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• 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: 15309691
• MDR Text Key: 298797498
• Report Number: 9681900-2022-00028
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

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: 110040
• Device Lot Number: RGAA2M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 02/24/2023
• Supplement Dates FDA Received: 09/28/2022; 02/24/2023
• 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