MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ AP; NEPHELOMETER, FOR CLINICAL USE

Catalog Number	448010
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ ap contamination was reported based on an increase in resistant and misidentified organisms on downstream instrumentation.The user decontaminated the device.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: a complaint on contamination associated with phoenix ap instrument was reported.The field service engineer (fse) was dispatched on site.The fse performed decontamination.After that, the issue was resolved.This is a confirmed failure of a bd product.The root cause of the failure is not known.The device history record review for the instrument is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.The service history review was completed and revealed no previous complaints related to this failure mode.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.Bd quality will continue to closely monitor for trends associated with this complaint.
Event or Problem Description
It was reported while using the bd phoenix¿ ap contamination was reported based on an increase in resistant and misidentified organisms on downstream instrumentation.The user decontaminated the device.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: a complaint on contamination associated with phoenix ap instrument was reported.The field service engineer (fse) was dispatched on site.The fse performed decontamination.After that, the issue was resolved.This is a confirmed failure of a bd product.The root cause of the failure is not known.The device history record review for the instrument is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.The service history review was completed and revealed no previous complaints related to this failure mode.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.Bd quality will continue to closely monitor for trends associated with this complaint.

• Brand Name: BD PHOENIX¿ AP
• Common Device Name: NEPHELOMETER, FOR CLINICAL USE
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22700848
• Report Number: 1119779-2025-02337
• Device Sequence Number: 8945075
• Product Code: JQX
• UDI-Device Identifier: 00382904480103
• UDI-Public: (01)00382904480103
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: Other
• Device Catalogue Number: 448010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown