BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AP

    MDR report key: 12628780 · Received October 13, 2021

    Report

    Report Number
    1119779-2021-01646
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    August 25, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQX
    UDI-DI
    00382904480103
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO SERVES TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT ON THE INSTRUMENT 448010 (PHOENIX AP), SERIAL NUMBER (B)(6) WHERE IT WAS REPORTED THAT THE INSTRUMENT HAD CONTAMINATION. PER THE CUSTOMER THE TUBING WAS REPLACED, AND NO FURTHER CONTAMINATION WAS SEEN. NO FURTHER INFORMATION WAS PROVIDED; THEREFORE, THE COMPLAINT IS NOT CONFIRMED. THE AP INSTRUMENT DOES NOT HAVE A SERVICE HISTORY OF THESE ISSUES AT TIME OF THIS EVENT. HOWEVER, BD WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDING. THE REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETE AND NO ISSUE WAS SEEN. A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS YIELDED NO TREND SEEN FOR THIS ISSUE AS OF JUNE 21. THIS HAS THE SAME HAZARD AS LINE 7 OF BALTRM448010APH REV 10: FALSE SUSCEPTIBILITY WHICH HAS A SEVERITY OF S4. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AP CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " 448010 - INSTRUMENT PHOENIX AP - RECONTAMINATION OF PLATES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AP CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " 448010 - INSTRUMENT PHOENIX AP - RECONTAMINATION OF PLATES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524511 BD PHOENIX¿ AP NEPHELOMETER, FOR CLINICAL USE JQX BECTON, DICKINSON & CO. (SPARKS) 448010 00382904480103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown