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

Model Number	IPN042498
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported "pilot cuff burst during cuff investigation.Clinical consequences: none as prior to use on a patient during inspect ion/functional testing".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturing site for investigation.The manufacturing site reports "the inflation balloon material of the complaint device was observed ruptured.The gluing at joint on the inflation balloon to inflation line was intact.The airway tube of the device was lightly yellowish due to multiple uses.The inflation balloon profile of the complaint device was slightly deformed / loss its resilience due to stress.The check valve of the device was tested.It was functioning.That means air can be blown into the lma proseal and can be released from the device via the check valve smoothly and no blockage found.In addition the manual vent of the plug is free from blockage and air can be released smoothly with the red plug.Dhr was reviewed.No abnormality was found." based in the investigation performed the reported complaint was confirmed.Over-inflation is a known cause that leads to rupture of the inflation balloon.During high temperature, vacuum and humid autoclaving environment, any air / moisture trapped inside the device will expand significantly and it will damage the properties of the device to an irreparable condition.It is suspected that there was some residual of air / moisture was left inside the device while re-processing / handling that causing the failure inadvertently.
Event or Problem Description
It was reported "pilot cuff brust during cuff investigation.Clinical consequences: none as prior to use on a patient during inspect ion/functional testing".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: 11317370
• Report Number: 9681900-2021-00003
• Device Sequence Number: 2737163
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: No Information
• Device Model Number: IPN042498
• Device Catalogue Number: 150040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1