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	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone #: (b)(6).D4.Medical device serial #: unknown h.4.Device manufacture date: unknown h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd phoenix¿ ap the user noted multidrug resistance in several isolates due to the instrument contamination.The device was decontaminated.No health impact or consequence reported.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information d4.Unique identifier (udi) #: (b)(4).D4.Medical device serial #: (b)(6).H4.Device manufacture date: 28-aug-2020.Investigation summary: a complaint was reported for antibiograms misidentification associated with phoenix ap instrument.Bd remote assistance suspected this might be due to contamination and will be sending guidance for cleaning.No further information was received.This is an unconfirmed failure of a bd product.The root cause of the failure was unable to be determined.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.Service history for this instrument was reviewed and no previous complaint related to this failure mode was revealed.No parts were replaced as part of this complaint, and therefore, no samples were returned, and no returned material investigation could occur.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 the user noted multidrug resistance in several isolates due to the instrument contamination.The device was decontaminated.No health impact or consequence reported.

• 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: 22531115
• Report Number: 1119779-2025-01759
• Device Sequence Number: 12745795
• Product Code: JQX
• UDI-Device Identifier: 00382904480103
• UDI-Public: (01)00382904480103
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2020
• 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