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

Model Number IPN042498

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event 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.

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 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
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11317370
• MDR Text Key: 233492385
• Report Number: 9681900-2021-00003
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1