STREAMLINE SURGICAL SYSTEM
Received Mar 30, 2026
Report 1000125279-2026-00014 · MDR key 24724324
Device
Generic name
Infusion Pump
Manufacturer
New World Medical, Inc.Model number
STREAMLINECatalog number
STREAMLINE
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hyphema
Narrative
Additional Manufacturer Narrative
THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE HYPHEMA AS A KNOWN COMPLICATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED, AS NO SPECIFIC SERIAL OR LOT INFORMATION WAS AVAILABLE. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VALIDATED PROCEDURES. AS THE DEVICE IS NOT AVAILABLE FOR RETURN, NO DEVICE MALFUNCTION COULD BE CONFIRMED.
Description of Event or Problem
HAD A PATIENT WHO DEVELOPED MICRO HYPHEMA AFTER A STREAMLINE ONE CLICK - DR. SAID HE DID NOT PRIME ON CLICK - WONDER IF IT WAS HYPER PRESSURIZED, IT WENT VIA360 AND HEME WAS COMING APPOSITIONAL TO THE WOUND, PATIENT DC 6 TREATMENTS AND A LONG GONIOTOMY.