MAUDE Adverse Event Report: CATALENT PHARMA SOLUTIONS ALBUTEROL SULFATE INHALATION AEROSOL

Lot Number 19MC-053

Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Consumer called perrigo on (b)(6) 2020 to report that the inhaler never dispensed any medication and the canister felt empty.Following receipt of the complaint sample at catalent, catalent notified perrigo on september 16, 2020 that testing of the returned complaint sample indicated an absence of propellant.Testing of the sample by bespak, the manufacturer of the actuator, indicated that the observed leakage likely occurred due to a gasket being out of position.

• Brand Name: ALBUTEROL SULFATE INHALATION AEROSOL
• Type of Device: ALBUTEROL SULFATE INHALATION AEROSOL
• Manufacturer (Section D): CATALENT PHARMA SOLUTIONS; 160 north pharma drive; morrisville NC 27560
• MDR Report Key: 10689869
• MDR Text Key: 211692045
• Report Number: 1000110912-2020-00003
• Device Sequence Number: 1
• Product Code: QKS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2021
• Device Lot Number: 19MC-053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1