MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922772
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: prior to use on patient, while testing the lma, the provider was not able to deflate the lma even after changing the syringe used 3 separate times.The reported defect was detected prior to use in a clinical setting.There was no patient involvement.
Additional Manufacturer Narrative
(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: prior to use on patient, while testing the lma, the provider was not able to deflate the lma even after changing the syringe used 3 separate times.The reported defect was detected prior to use in a clinical setting.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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
(b)(4).The product received with disinfection tag and product com plaint description.A deflate and inflate test was carried out to test the product functionality and cpv is working or not.Result 'passed' as the product can be deflated and inflated with no issue and no leak was observed.Cpv is connected well to the syringe.The product was fully deflated.The product was inflated until the cpv indicator moves to green.The product was inflated more until the cpv indicator moves to red zone.The dhr was reviewed and no abnormalities were found.Assembly dhr for the cuff pilot valve (cpv) used was reviewed and there was no issue with the cpv lot used for the final assembly product.Based on the review of the ohr and nonconformance (nc) list, there is no issue of product cannot be deflated were found related with the finished packaging or assembly product lot.Based on the testing performed on the sample received, the product was able to be deflated and inflated.No leak is observed, and the test conclude that the sample has no problem.Therefore, the root cause after the complaint sample received and review is "no problem found on sample".Based on the complaint description of "does not deflate - prior to use", reviewing of the ohr of the packaging and assembly lot, reviewing the nc list, and review the complaint sample, it is concluded that the complaint root cause is "no problem found on the sample".Therefore, no further escalation or action is required.
Event or Problem Description
Reported issue: prior to use on patient, while testing the lma, the provider was not able to deflate the lma even after changing the syringe used 3 separate times.The reported defect was detected prior to use in a clinical setting.There was no patient involvement.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 4
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15890289
• Report Number: 3011137372-2022-00229
• Device Sequence Number: 15151891
• Product Code: CAE
• UDI-Device Identifier: 15060112318181
• UDI-Public: 15060112318181
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2022

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: 05/12/2025
• Device Model Number: IPN922772
• Device Catalogue Number: 105200-000040
• Device Lot Number: 11F22E0053
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 02/14/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/28/2022; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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.; NONE REPORTED.
• Patient Sex: Unknown