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

Model Number	IPN922773
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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.
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).All complaints are trended across product families on a monthly basis.The dhr for the packaging lot 11f22e0212 was reviewed and found no abnormalities with the complaint lot.Dhr for the assembly process lot affected was reviewed and there were no nonconformances issued.Assembly dhr for inflation line to cuff pilot valve used was reviewed and there was no issue with the cpv lot for the final assembly product.Based on the review of the dhr and nonconformance list there is not issue of product cannot be deflated were found related with the finished packaging or assembly product lot.The investigation shall be reissued or carried out once the complaint sample is returned to kulim plant.Therefore, the current root cause of the product, unable to be deflated, is concluded as "undetermined/unknown".Further investigation shall be performed once the complaint sample is returned to kulim.

• 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): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16018182
• Report Number: 3011137372-2022-00246
• Device Sequence Number: 17812030
• 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): 11/28/2022

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: 11/28/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/23/2023
• 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