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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 4-PORT MANIFOLD; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 4-PORT MANIFOLD; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 0702020000
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
Additional information added for d10, h3 device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.H3 other text : discarded by user.
 
Event Description
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.
 
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Brand Name
NEPTUNE 2 4-PORT MANIFOLD
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9580443
MDR Text Key174674756
Report Number0001811755-2020-00041
Device Sequence Number1
Product Code JCX
UDI-Device Identifier37613154688280
UDI-Public37613154688280
Combination Product (y/n)N
PMA/PMN Number
K132671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0702020000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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