MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) AND LMA UNIQUE (SIL; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922773
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the cuff stayed in the red zone when inflated then it was unable to be inflated or deflated with syringe.The defect was detected just before insertion into the patient.The intervention was to grab another one and keep bagging.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn#(b)(4).The device history was reviewed and there was no abnormality found.Based on the complaint description of "will not deflate prior to use", reviewing of the dhr of the packaging and assembly lot, reviewing the nc list, it was concluded that the complaint root cause is undetermined / unknown as the assembly or packaging process for the affected lot manufacturing process did not have any record on the similar issue.Further investigation shall be performed once the complaint sample was returned to kulim.
Event or Problem Description
Reported issue: the cuff stayed in the red zone when inflated then it was unable to be inflated or deflated with syringe.The defect was detected just before insertion into the patient.The intervention was to grab another one and keep bagging.

• Brand Name: LMA UNIQUE (SILICONE CUFF) AND LMA UNIQUE (SIL
• Common Device Name: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16085635
• Report Number: 9681900-2023-00001
• Device Sequence Number: 15136789
• Product Code: CAE
• UDI-Device Identifier: 15060112318198
• UDI-Public: 15060112318198
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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 Model Number: IPN922773
• Device Catalogue Number: 105200-000050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown