MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922891
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: 15mm connector of lma proseal #4 snapped off when the doctor tried to connect to circuit without much force.The device was used only 20 times.There was no reported injury.
Additional Manufacturer Narrative
(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.
Additional Manufacturer Narrative
Qn#(b)(4).One lma proseal was returned from on grounds of "hole in mask prior to use on a patient".The record card received indicated that the device was used 20 times.The outer profile was yellowish due to multiple re-uses.The lot number and product were received as per the complaint description.The connector broke was not available because the cracked part was not received with the device.Other part of the connector was attached to the airway tube area.Autoclaving parameter adopted for reprocessing the devices were reported as per complaint description.It is possible that this could have been caused by the detergent or cleaning agent used, which might have weakened the connector.In addition, the mask has been used 20 times prior to this incident and therefore, this is not considered to be a manufacturing fault.The device history was reviewed, and no issues related to the connector was observed during the quality inspection.In conclusion, potential damage was caused by the detergent or cleaning agent used which might have weakened the connector.In addition, the mask has been used 20 times prior to this incident and therefore this is not considered to be a manufacturing fault.
Event or Problem Description
Reported event: 15mm connector of lma proseal #4 snapped off when the doctor tried to connect to circuit without much force.The device was used only 20 times.There was no reported injury.

• Brand Name: LMA PROSEAL SIZE 4
• 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: 16373540
• Report Number: 9681900-2023-00005
• Device Sequence Number: 6748851
• Product Code: CAE
• UDI-Device Identifier: 15060112318730
• UDI-Public: 15060112318730
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 06/30/2025
• Device Model Number: IPN922891
• Device Catalogue Number: 150040
• Device Lot Number: QFAAGV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown