MAUDE Adverse Event Report: AMSINO INTERNATIONAL, INC. 2000ML RECEPTAL¿ CANISTER; BOTTLE, COLLECTION, VACUUM

Catalog Number 43042-01

Device Problems Decrease in Suction (1146); Material Twisted/Bent (2981)

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

Event Date 12/11/2019

Event Type  malfunction  

Event Description

It was reported by anesthesia that the blue portion of the suction kinked off, not allowing the patient to be suctioned.

• Brand Name: 2000ML RECEPTAL¿ CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): AMSINO INTERNATIONAL, INC.; 708 corporate center drive; pomona CA 91768
• MDR Report Key: 9457469
• MDR Text Key: 170452135
• Report Number: 9457469
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43042-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Type of Device Usage: N
• Patient Sequence Number: 1