MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 105300-000050

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The report states, "debris".No patient harm or injury.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.

Event Description

The report states, "debris".No patient harm or injury.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).Additional information received on 26 june 2023 states that the detail of the found debris was "unknown" and it was discovered prior to use in the clinical setting, no patient involvement.The current status of the patient is unknown however the surgery was completed and the patient was discharged home.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17198990
• MDR Text Key: 318033319
• Report Number: 3011137372-2023-00163
• 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
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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 Catalogue Number: 105300-000050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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