MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000040

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that the device was discarded by the user.The investigation into this complaint is still in progress at the time of this report.

Event Description

Customer complaint alleges during "insertion of two lmas, visual distortion of the mechanism inside the cuff pilot as well air could be inserted into the lma cuff but not withdrawn".No patient harm reported.See companion mdr # 3011137372-2019-00010 for additional device reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

Customer complaint alleges during "insertion of two lmas, visual distortion of the mechanism inside the cuff pilot as well air could be inserted into the lma cuff but not withdrawn".(continued) no patient harm reported.See companion mdr # 3011137372-2019-00010 for additional device reported.

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8228230
• MDR Text Key: 132503720
• Report Number: 3011137372-2019-00011
• Device Sequence Number: 1
• Product Code: CAE
• 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: 12/19/2018

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: 08/28/2021
• Device Catalogue Number: 105200-000040
• Device Lot Number: NRAC92
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.