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

Catalog Number	150040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9681900-2023-00028
• Device Sequence Number: 11751182
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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 Catalogue Number: 150040
• Device Lot Number: RFAAT4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown