BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 10775231 · Received November 2, 2020

    Report

    Report Number
    2243072-2020-01771
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 8, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JPH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-09. H6: INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 00203 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ NOT MIXING. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND TWO LOOSE SCREWS WERE FOUND, WITHIN THE INSTRUMENT, THAT HOLDS THE TUBE HOLDER. THE SCREWS WERE RESEATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD SEDI-40 THE MIXER IS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MIXER DOES NOT WORK ANY MORE.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A BD SEDI-40 THE MIXER IS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MIXER DOES NOT WORK ANY MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234617 BD SEDI-40 ESR INSTRUMENT JPH BECTON DICKINSON NA

    Patients

    Seq Age Sex Outcome Treatment
    1