MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Model Number IPN922811

Device Problem Material Rupture (1546)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported that"the doctor found cuff broken when opening the package during clinical setting before using on patient".The device was not used on a patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A photo was provided by the customer and it was observed that the cuff had burst.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that"the doctor found cuff broken when opening the package during clinical setting before using on patient".The device was not used on a patient.

Manufacturer Narrative

(b)(4).The sample was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports "actual complaint sample was received for observation.It was received with cuff protector and vent tab install to the product.Open the cuff protector and reviewed on the cuff condition.Cuff burst at two area, at the distal tip area and the proximal end of cuff.Reviewed on the vent tab installation area found the vent tab was not touching the check valve.Remove the check valve and identify the component was broken.Suspect that cuff deforms during sterilization process when vent tab dislodged or probably not assembled properly before sterile.Dhr was reviewed.No abnormality was found." manufacturing site conclusion: "based on the complaint description and review of dhr for the affected lot, the lot was produced in (b)(6) 2019 and found no abnormalities.There was also no nc raised during production of the lot.During review on visual inspection on complaint sample received, found vent tab that install to the product was broken.High potential the cuff burst occur during sterilization process and the product undergoes sterile process with assembled with broken vent tab.Therefore, no free flow of air in and out of the cuff resulting the cuff was over inflated during sterile.In conclusion, the root cause of the failure was manufacturing or supplier related complaint.".

Event Description

It was reported that"the doctor found cuff boken when opening the package during clinical setting before using on patient".The device was not used on a patient.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: LMA SUPREME
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14373570
• MDR Text Key: 292178854
• Report Number: 9681900-2022-00014
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318099
• UDI-Public: 15060112318099
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: IPN922811
• Device Catalogue Number: 175040
• Device Lot Number: PMDGGD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2022
• 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: N/A.; N/A.; N/A.