MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 4-PORT MANIFOLD; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number	0702020000
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Event or Problem 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.
Additional 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.

• Brand Name: NEPTUNE 2 4-PORT MANIFOLD
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9580445
• Report Number: 0001811755-2020-00042
• Device Sequence Number: 3244730
• Product Code: JCX
• UDI-Device Identifier: 37613154688280
• UDI-Public: 37613154688280
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0702020000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1