NEPTUNE 2 4-PORT MANIFOLD 0702020000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for NEPTUNE 2 4-PORT MANIFOLD 0702020000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[174674740] It was reported that during a neurovascular procedure performed by the neurosurgery department at the user facility, the manifold clogged. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2020-00042
MDR Report Key9580445
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-13
Date of Report2020-01-13
Date of Event2019-12-16
Date Mfgr Received2019-12-16
Date Added to Maude2020-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ZACH BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEPTUNE 2 4-PORT MANIFOLD
Generic NameAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Product CodeJCX
Date Received2020-01-13
Catalog Number0702020000
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.