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

Catalog Number 105300-000050

Device Problem Material Separation (1562)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: upon extubation the cuff of the lma detached from the tube.The physician was able to reach down and grab the cuff and retrieve it.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

Manufacturer Narrative

Qn# (b)(4).A sample was not returned for investigation at the manufacturing site.The manufacturer reported: "no sample was returned for investigation.Dhr for the packaging lot was reviewed and no abnormalities were found with the complaint lot.No findings or reject on different size product was observed during the packaging process.From the complaint description, the complaint is concluded as 'manufacturing related' as the failure described was the same as previous complaint received.There was also no restrain or such as patient bite or intention to remove the product by force that could cause the failure.Therefore, this complaint was conducted as confirmed complaint and shall be future evaluated in the investigation and risk evaluation that was opened to evaluate and assess the risk of the product in the market." teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that: upon extubation the cuff of the lma detached from the tube.The physician was able to reach down and grab the cuff and retrieve it.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18214920
• MDR Text Key: 329071549
• Report Number: 3009307931-2023-00003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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: #11F22K009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/20/2023
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.
• Patient Age: 62 YR
• Patient Sex: Male