MAUDE Adverse Event Report: AMSINO HEALTHCARE USA AMSINO; 1000 ML AMSURE STERILE WATER NEBULIZER BOTTLE, USP.

Model Number AS1065

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The date of the incident was not specified.

Event Description

The 1000 ml amsure® sterile water nebulizer bottle, usp was difficult to open, and punctured the hand of the customers employee that opened the container for use.

• Brand Name: AMSINO
• Type of Device: 1000 ML AMSURE STERILE WATER NEBULIZER BOTTLE, USP.
• Manufacturer (Section D): AMSINO HEALTHCARE USA; 330 corporate woods parkway; vernon hills IL 60061
• Manufacturer Contact: esteban encarnacion ; 330 corporate woods pkwy; vernon hills 60061 ; 8473831416
• MDR Report Key: 18727459
• MDR Text Key: 335823611
• Report Number: 1417519-2023-00004
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: AS1065
• Device Catalogue Number: AS1065
• Device Lot Number: H767
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1