MAUDE Adverse Event Report: TELEFLEX LMA; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 125040

Device Problems Material Separation (1562); Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2020

Event Type  Injury  

Event Description

Teleflex lma became separated during extubating, tube removed, and cuff became dislodged in patient airway.Patient had to be re paralyzed, open jaw and manually remove cuff.Fda safety report id # (b)(4).

• Brand Name: LMA
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX
• MDR Report Key: 11108262
• MDR Text Key: 225172726
• Report Number: MW5098637
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2020

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: 06/28/2020
• Device Model Number: 125040
• Device Lot Number: PMBPL2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR