MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. AS B & F MEDICAL SINGLE USE NEBULIZER WITH TUBING; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 64085

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/16/2018

Event Type  Injury  

Event Description

Oxygen tubing would not stay connected to nebulizer under pressure.The fitting at the end of the tubing did not appear to fit the nebulizer correctly.The tubing repeatedly popped off during patient care, the emt in charge had to tape the tubing in place.The poor fit was verified by other emt's.

• Brand Name: SINGLE USE NEBULIZER WITH TUBING
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC. AS B & F MEDICAL; st. louis MO 63110
• MDR Report Key: 8074750
• MDR Text Key: 127528637
• Report Number: MW5081314
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2018

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 Model Number: 64085
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• 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