MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SI CUFF CPV SIZE 3

Model Number	IPN041107
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.
Event or Problem Description
It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.The sample was functionally tested and it was found that the device could be inflated and deflated with a syringe.No issues were encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.
Event or Problem Description
It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.

• Brand Name: LMA UNIQUE SI CUFF CPV SIZE 3
• Common Device Name: LMA UNIQUE
• 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
• MDR Report Key: 12321137
• Report Number: 9681900-2021-00027
• Device Sequence Number: 11513670
• Product Code: CAE
• UDI-Device Identifier: 05060112313578
• UDI-Public: 05060112313578
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2021

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 Expiration Date: 05/28/2022
• Device Model Number: IPN041107
• Device Catalogue Number: 105200-000030
• Device Lot Number: PRAEKB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 01/04/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/09/2021; 01/04/2022
• 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
• Patient Sex: Unknown