MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number UNK_INS

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : awaiting additional information.

Event Description

It was reported via medwatch mw5148449 that potential use error/misuse may be occurring at the user facility, as it was reported the user may be "hooking the neptune to the plura vac".No product malfunction or actual adverse event has been identified at this time.No additional information has been provided but has been requested.If additional information becomes available, the event will be re-evaluated.

Event Description

It was reported via medwatch mw5148449 that potential use error/misuse may be occurring at the user facility, as it was reported the user may be "hooking the neptune to the plura vac".No product malfunction or actual adverse event has been identified at this time.No additional information has been provided.

Manufacturer Narrative

The device was not available for evaluation; therefore, a root cause could not be determined for the event.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18497900
• MDR Text Key: 333198248
• Report Number: 3015967359-2024-00045
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1