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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It is reported that "as the anesthesiologist was removing the lma at the end of the procedure, the ventilation tube detached from the cuff leaving the cuff in place.The anesthesiologist was able to extract the cuff by the inflation port tubing.Please note that the patient was not resisting or biting on the lma, so this seemed to be a random event".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "detached - cuff" was confirmed based upon the sample received.The customer returned one unit of 105200-000030 lma unique silicone cuff pilot size 3.Visual examination of the returned sample revealed that glue was observed at the joint surface and on the airway tube surface joint area.The returned sample appeared used as there was biological material present on the device.A device history record review was performed, and no relevant findings were identified.The root cause of the complaint is considered as a "manufacturing related" issue as per the returned sample.Therefore, this complaint was concluded as confirmed.An investigation was initiated to further investigate the issue.The investigation is still on-going.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It is reported that "as the anesthesiologist was removing the lma at the end of the procedure, the ventilation tube detached from the cuff leaving the cuff in place.The anesthesiologist was able to extract the cuff by the inflation port tubing.Please note that the patient was not resisting or biting on the lma, so this seemed to be a random event".No patient harm or injury.The patient status is reported as "fine".

• 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; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17643392
• MDR Text Key: 322193798
• Report Number: 9681900-2023-00023
• 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: 08/15/2023

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
• Device Lot Number: 11F22E0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2022
• 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: N/A.; N/A.