MAUDE Adverse Event Report: TELEFLEX INCORPORATED LMA UNIQUE (SILICONE) CUFF PILOT 2.5; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Catalog Number 105200-000025

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Once the patient was sedated with the new lma in place, the proceduralist inserted the bronchoscopy into the patient and observed an unusual finding/object in the patient¿s airway.Neither the proceduralist nor the anesthesiologist could identify the object.After multiple attempts to suction out the unknown item, the anesthesiologist pulled the originally inserted lma and replaced it with a new lma.Under inspection of the original lma, we discovered a small piece of the plastic that looks like the same material and color of the inflatable cuff of the lma.The loose piece of plastic that was seen in the airway was attached by a [invalid] of saliva at the end of the lma.Upon continuing the bronchoscopy no further evidence of the loose plastic part were seen.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 2.5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX INCORPORATED
• MDR Report Key: 18588774
• MDR Text Key: 333957276
• Report Number: MW5150760
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2024

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: 105200-000025
• Device Lot Number: 11F23A0090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White