MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 4

Catalog Number 105200-000040

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint was reported as: lma unique with silicone routinely flips sideways when being inserted from oral pharynx to hypo pharynx."it doesn't fit well" after attempting different insertion technique and sizing.It was reported the user is not ventilating successfully and needs to use another product to be successful.There was no patient harm reported.Patient condition reported as "fine".

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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint was reported as: lma unique with silicone routinely flips sideways when being inserted from oral pharynx to hypo pharynx."it doesn't fit well" after attempting different insertion technique and sizing.It was reported the user is not ventilating successfully and needs to use another product to be successful.There was no patient harm reported.Patient condition reported as "fine".

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8975570
• MDR Text Key: 156929113
• Report Number: 3011137372-2019-00291
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

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 Catalogue Number: 105200-000040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED