MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 3; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 105200-000030

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the "lma cuff has separated from the tube".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The customer report of a " cuff has separated from the tube" was not able to be confirmed by visual inspection of the customer supplied photos.A device history record review was performed, and no relevant findings were identified.The usage date or the event date of the product is 25 aug 2023 that is exceeding the assigned expiry date more than 13 months.Therefore, the root cause of the issue is concluded as "unintentional user error related".Therefore, the complaint is concluded as non-manufacturing related and no escalation or additional action are required.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the "lma cuff has separated from the tube".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 3
• 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: 17719329
• MDR Text Key: 323064792
• Report Number: 3009307931-2023-00002
• 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: 08/25/2023

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: 105200-000030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/10/2023
• 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