MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 4

Model Number IPN922790

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

It was reported that "the doctor found foreign material when doing clinical setting before using on patient.Then changed new one, no impact on patient.".No patient involvement.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Other remarks and corrected data: n/a.

Manufacturer Narrative

(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.

Event Description

It was reported that "the doctor found foreign material when doing clinical setting before using on patient.Then changed new one, no impact on patient." no patient involvement.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: LMA GASTRO CUFF PILOT SIZE 4
• Type of Device: LMA GASTRO CUFF PILOT
• 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
• MDR Report Key: 17154538
• MDR Text Key: 317912226
• Report Number: 9681900-2023-00017
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112317955
• UDI-Public: 15060112317955
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

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 Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: IPN922790
• Device Catalogue Number: 1E5040
• Device Lot Number: RMAYNK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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