MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. STREAMLINE SURGICAL SYSTEM; INFUSION PUMP

Model Number	10-0066
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the indicated lot was reviewed and no issues were observed.Product was manufactured, tested, and released per validated procedures.The device was discarded by the user facility and unable to be evaluated.User facility was contacted for further information regarding the event, however no response was received.If additional information is received, an addendum will be submitted.There are several factors that can contribute to the development of a cyclodialysis cleft after surgery, including the type of surgical procedure performed, the degree of trauma to the eye during surgery, and the patient's underlying health status.As device evaluation could not be conducted and with no additional information from the user facility, no conclusions could be made on the cause of the adverse event in relation to the device.
Event or Problem Description
Surgical sales consultant reported "[doctor] determined the patient experienced a cyclodialysis cleft at the pow1 patient visit.At the pod1, the surgeon feedback was the iop was <10 mmhg.After the pow1, the surgeon communicated via text the iop was 3 mmhg and probably experienced a cyclodialysis cleft.".

• Brand Name: STREAMLINE SURGICAL SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9098705446
• MDR Report Key: 16710605
• Report Number: 1000125279-2023-00014
• Device Sequence Number: 13874949
• Product Code: MRH
• UDI-Device Identifier: 00892064002010
• UDI-Public: (01)00892064002010(11)220416(17)230416(10)D1022
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 10-0066
• Device Catalogue Number: 10-0066
• Device Lot Number: D1022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown