MAUDE Adverse Event Report: PERRIGO/CATALENT PHARMA SOLUTIONS, LLC NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number 19MC092

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/09/2020

Event Type  malfunction  

Event Description

Plastic part of inhaler is not allowing a spray to come out.Patient took the canister and put it in a plastic sleeve from a competitor and the inhaler worked.

• Brand Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PERRIGO/CATALENT PHARMA SOLUTIONS, LLC
• MDR Report Key: 10178757
• MDR Text Key: 196199831
• Report Number: MW5095096
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 45802008801
• UDI-Public: 45802008801
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2021
• Device Lot Number: 19MC092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR