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

Model Number STREAMLINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Visual Impairment (2138)

Event Date 08/01/2022

Event Type  Injury  

Event Description

Doctor reported, "pt had a goniotomy with streamline and a small amount of heme was noticed during the sx.Dr said the blue tip was in the way of the procedure and while he thinks he pressed it on the tm but unsure exactly.Over the course of the week the patients vision progressively got worse and the cornea had an orange tint that has now turned brown.Pt is now seeing a corneal specialist for further evaluation.".

Manufacturer Narrative

Identifying information for product (lot# and sn#) were not available.Deliveries to this hospital were reviewed and found that 4 streamline lots were sold to this facility.The 4 device history records were reviewed with no issues observed.Product was manufactured, tested, and released per validated procedures.Device was discarded after surgery and is not available for review.

• Brand Name: STREAMLINE SURGICAL SYSTEM
• Type of Device: PUMP, INFUSION, OPHTHALMIC
• 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: 15396849
• MDR Text Key: 299660131
• Report Number: 1000125279-2022-00032
• Device Sequence Number: 1
• Product Code: MRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: STREAMLINE
• Device Catalogue Number: STREAMLINE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian