MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 150040

Device Problem Leak/Splash (1354)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that:.Places laryngeal mask '4 where there is a leak in the anaesthesia machine, the balloon is inflated and after a while it deflates.The reported defect was detected prior to use (in a clinical setting).There was no patient involvement.

Event Description

It was reported that:.Places laryngeal mask '4 where there is a leak in the anaesthesia machine, the balloon is inflated and after a while it deflates.The reported defect was detected prior to use (in a clinical setting).There was no patient involvement.

Manufacturer Narrative

(b)(4).The manufacturer reported: "the returned complaint sample was unpacked and unloaded from the original packaging upon receipt.Its product pouch was not returned.Record card also not available.Since functional test was conducted to actual complaint received, and no abnormalities found related to cuff leak.This complaint was identifying as non-manufacturing related (no problem found on sample)." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: LMA PROSEAL SIZE 4
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18265658
• MDR Text Key: 329718271
• Report Number: 9681900-2023-00028
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 150040
• Device Lot Number: RFAAT4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2023
• 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