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

Model Number	1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): AMSINO INTERNATIONAL, INC.; 708 corporate center drive; pomona CA 91768
• MDR Report Key: 8468833
• Report Number: 8468833
• Device Sequence Number: 2006324
• Product Code: KYZ
• UDI-Device Identifier: 10704411008460
• UDI-Public: (01)10704411008460
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/21/2019
• Report Date (Section F): 03/21/2019

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
• Operator of Device: Other
• Device Model Number: 1
• Device Catalogue Number: AS011P
• Device Lot Number: 129578KS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/21/2019