MAUDE Adverse Event Report: AMSINO INTERNATIONAL, INC. AMSURE® BULB IRRIGATION SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 1

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 03/20/2019

Event Type  malfunction  

Event Description

While opening items onto the sterile field, the scrub technician noticed a strange substance inside of a sterile peel packed bulb syringe on the bulb before it came into contact with the field.It was taken out of the room and reported.Ref: as011p; lot: 129578ks.

• Brand Name: AMSURE® BULB IRRIGATION SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): AMSINO INTERNATIONAL, INC.; 708 corporate center drive; pomona CA 91768
• MDR Report Key: 8468833
• MDR Text Key: 140443355
• Report Number: 8468833
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10704411008460
• UDI-Public: (01)10704411008460
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1
• Device Catalogue Number: AS011P
• Device Lot Number: 129578KS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1