MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SI CUFF CPV SIZE 4

Model Number IPN914129

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported "a nurse, noted that when the manometer was deflated to be inserted, the measurement gauge became stuck so they were not able to appropriately read the degree of inflation".No patient involvement reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

It was reported "a nurse, noted that when the manometer was deflated to be inserted, the measurement gauge became stuck so they were not able to appropriately read the degree of inflation".No patient involvement reported.

• Brand Name: LMA UNIQUE SI CUFF CPV SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12180857
• MDR Text Key: 261952289
• Report Number: 3011137372-2021-00168
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112315449
• UDI-Public: 15060112315449
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: IPN914129
• Device Catalogue Number: 105200-000040
• Device Lot Number: QMBB67
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1