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 08/25/2023

Event Type  malfunction  

Event Description

It was reported that during use after intubation, "the lma cuff has separated from the tube".Further information states that there was "no desaturation as it was recognized when they moved the lma inside the patient's mouth.The cuff was removed by pulling on the inflation tube".No patient harm or injury.

Manufacturer Narrative

Qn (b)(4).

Manufacturer Narrative

Qn# (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.The customer provided pictures for analysis.From the complaint and lot details, the root cause of this issue is concluded as "unintentional user error related" as the product was used over the expiry date of the product lot.Therefore, the complaint is concluded as non-manufacturing related and no escalation or additional action are required.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that during use after intubation, "the lma cuff has separated from the tube".Further information states that there was "no desaturation as it was recognized when they moved the lma inside the patient's mouth.The cuff was removed by pulling on the inflation tube".No patient harm or injury.

• 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: 17700759
• MDR Text Key: 322867370
• Report Number: 3009307931-2023-00001
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/26/2023
• 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
• Treatment: N/A.; N/A.