MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number 100050

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

At the time of uncovering the classic laryngeal mask '5, a balloon with a hole is observed.The reported defect was detected prior to use (in a clinical setting).There was no patient involvement.

Manufacturer Narrative

(b)(4), one lma classic reported from colombia on ground of "balloon with hole".The actual complaint sample was received.The product size was same as complaint description.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Review on actual complaint sample and found there was tear on pilot balloon area.Potentially, the user might mishandle the device during cleaning / autoclave.The device worked for 16 times used before problem occurred.In ifu, there also caution to careful handling is essential due the lma classic is made of medical-grade silicone which can be torn or perforated.Always avoid contact with sharp or pointed objects.There is complaint conclude as unintentional user error related.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

At the time of uncovering the classic laryngeal mask '5, a balloon with a hole is observed.The reported defect was detected prior to use (in a clinical setting).There was no patient involvement.

• Brand Name: LMA CLASSIC SIZE 5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• 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: 18746399
• MDR Text Key: 336086888
• Report Number: 3009307931-2024-00008
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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 Catalogue Number: 100050
• Device Lot Number: 8YUAEPTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/22/2024
• 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