MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Model Number	IPN922811
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9681900-2022-00014
• Device Sequence Number: 17639705
• Product Code: CAE
• UDI-Device Identifier: 15060112318099
• UDI-Public: 15060112318099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 08/16/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/09/2022; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.
• Patient Sex: Unknown