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

Lot Number 19MC-056

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

A pharmacy called perrigo on 07/13/2020 to report that an inhaler returned from a patient felt empty prior to delivery of the full 200 doses.Following receipt of the complaint sample at catalent, catalent notified perrigo on 10/02/20 that testing of the returned complaint sample indicated possible leakage of propellant.Further analysis of the returned complaint sample by bespak, the manufacturer of the actuator, is ongoing.

• 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: 10775631
• MDR Text Key: 214395626
• Report Number: 1000110912-2020-00004
• 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: distributor
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2021
• Device Lot Number: 19MC-056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 10/02/2020
• 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: Unknown
• Patient Sequence Number: 1