MAUDE Adverse Event Report: HALYARD / AVANOS MEDICAL, INC. IN LINE SUCTION ; CATHETER, SUCTION, TRACHEOBRONCHIAL

Lot Number 30003200

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  Injury  

Event Description

Per superior of respiratory investigation was not the vent tubing; was inline suction.Stated same snapped in half without cause of movement of pt of pressure.Has equipment in possession.Fda safety report id# (b)(4).

• Brand Name: IN LINE SUCTION
• Type of Device: CATHETER, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): HALYARD / AVANOS MEDICAL, INC.
• MDR Report Key: 9739394
• MDR Text Key: 180744425
• Report Number: MW5093162
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 30003200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR