MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number IPN047595

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Complaint from medwatch: it was reported "teleflex lma became separated during extubation.Tube removed and cuff became dislodged in patient airway.Patient had to be paralyzed, open jaw and manually remove cuff".No patient injury, harm, or desaturation reported.Patient condition unknown at time of report.

Manufacturer Narrative

(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

Complaint from medwatch: it was reported "teleflex lma became separated during extubation.Tube removed and cuff became dislodged in patient airway.Patient had to be paralyzed, open jaw and manually remove cuff".No patient injury, harm, or desaturation reported.Patient condition unknown at time of report.

• Brand Name: LMA UNIQUE SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11345711
• MDR Text Key: 232469089
• Report Number: 9681900-2021-00005
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112314718
• UDI-Public: 15060112314718
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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 Expiration Date: 06/28/2022
• Device Model Number: IPN047595
• Device Catalogue Number: 125040
• Device Lot Number: PMBPL2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Life Threatening; Required Intervention