MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE PRECURVED CPV SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number	1B2040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the user attempted to inflate the cuff during use, but air would not come into it.Therefore, a new unit was used instead.No injury to the patient occurred".
Event or Problem Description
It was reported that "the user attempted to inflate the cuff during use, but air would not come into it.Therefore, a new unit was used instead.No injury to the patient occurred".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "complaint sample was returned to kulim.There is a disinfection tag available on the plastic packaging of the sample.The sample was subjected to deflation test and inflation test and each test was able to be performed on the sample.No issue with the sample.A device history record was reviewed, and no abnormalities were found with the complaint lot.The complaint root cause was "no problem found on sample" as the testing performed on the sample returned found that the product is functioning as intended.No corrective or preventative action are required as there was no problem found on the returned sample.The sample was functioning properly, including the cuff pilot valve (cpv), and no leaks were observed.It was noted that air would not enter the cuff when the cuff pilot was not properly connected to the syringe.Additionally, the product was only unable to inflate when inserted into the patient's pharynx, though it was able to be deflated by the user before insertion.Therefore, no escalation or further action is required." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: LMA FLEXIBLE PRECURVED CPV 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: 20844554
• Report Number: 9681900-2024-00010
• Device Sequence Number: 3838594
• Product Code: CAE
• UDI-Device Identifier: 15060112319720
• UDI-Public: (01)15060112319720(11)240122(17)270121(10)11F24A0231(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1B2040
• Device Lot Number: 11F24A0231
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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