MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MICROFRANCE AND INTEGRA ENT OROTRACHEAL INJECTOR NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

During vocal cord injection, part of the microfrance and integra orotracheal needle broke off in the patient's throat.The plastic cover, there was a small piece of the plastic sheath that was still attached onto the cannula where the equipment had fractured.After a few attempts lasting approximately 15 minutes, the needle piece was retrieved.Fda safety report id#: (b)(4).

• Brand Name: MICROFRANCE AND INTEGRA ENT OROTRACHEAL INJECTOR NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 13002230
• MDR Text Key: 282342665
• Report Number: MW5106022
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White