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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATALENT PHARMA SOLUTIONS ALBUTEROL SULFATE INHALATION AEROSOL
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CATALENT PHARMA SOLUTIONS ALBUTEROL SULFATE INHALATION AEROSOL Back to Search Results
Lot Number 19MC-001
Device Problems Defective Device (2588); Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer called perrigo on (b)(6) 2020.The customer reported nothing came out of the inhaler, and she could not remove the canister.The complaint sample was received at catalent, the product manufacturer.Testing done by catalent determined the canister was able to be removed.The canister was found to be empty, possibly due to leaking.Additional testing of the sample by bespak, the manufacturer of the actuator, confirmed the gasket within the actuator was out of position.Catalent notified perrigo on 08/27/20 of the sample testing results.Investigation of the complaint is ongoing.
 
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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 Key10576686
MDR Text Key208825975
Report Number1000110912-2020-00002
Device Sequence Number1
Product Code QKS
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/14/2021
Device Lot Number19MC-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2020
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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