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

Model Number	IPN042498
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "a doctor found that after inflating the cuff, its shape was not symmetrical".No patient involvement reported.
Additional Manufacturer Narrative
Qn#20038966 the sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was perfo rmed and it was observed that the airway tube of the device was slightly yellowish due to multiple uses.It was also observed that the cuff was bulging due to stress.Functional testing was also performed and it was found that the check valve of the device was fun ctional; it means air in the device can be released and blow out through the check valve normally.There was no blockage on red plug.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The manufacturing site reports "air pressure is a known cause that lead to cuff herniation/cuff deformation of the lma mask.Customer is kindly reminded during high temperature, vacuum and humid autoclaving environment, any air/moisture left inside the cuff will expand significantly and it will damage the properties of the components of the device to an irreparable condition.It is highly suspected that some residual of air/moisture was left inside the device while handling/reprocessing that causing the failure inadvertently.Customer is also reminded to completely deflate the cuff before autoclaving it.".
Event or Problem Description
It was reported that "a doctor found that after inflating the cuff, its shape was not symmetrical".No patient involvement reported.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11773437
• Report Number: 9681900-2021-00013
• Device Sequence Number: 3438659
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN042498
• Device Catalogue Number: 150040
• Device Lot Number: 8VVAJLGD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.