MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 5

Catalog Number 105200-000050

Device Problem Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the device would not seat well upon three attempts by experienced providers for a general anesthesia case.Patient had to be intubated and was given a muscle relaxant.Customer reported that upon emergence the patient coughed against the ett and desaturated into the 80's.The anesthesiologist was called to the room and reintroduced anesthesia to attempt a smoother wake up.The patient again had desaturation into the 80's.Patient was eventually woken up with no long term harm, but the difficulty with emergence added 15 minutes to the or time at the end of the case.

Event Description

Customer reported the device would not seat well upon three attempts by experienced providers for a general anesthesia case.Patient had to be intubated and was given a muscle relaxant.Customer reported that upon emergence the patient coughed against the ett and desaturatated into the 80s.The anesthesiologist was called to the room and reintroduced anesthesia to attempt a smoother wake up.The patient again had desaturation into the 80s.Patient was eventually woken up with no long term harm, but the difficulty with emergence added 15 minutes to the or time at the end of the case.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed on a potential lot number (nrafvp) 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.

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 5
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9181135
• MDR Text Key: 166754769
• Report Number: 3011137372-2019-00341
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 105200-000050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MUSCLE RELAXANTANESTHESIA; MUSCLE RELAXANTANESTHESIA
• Patient Outcome(s): Required Intervention