BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 10387515 · Received August 10, 2020

    Report

    Report Number
    2243072-2020-01218
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 14, 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: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 9/1/2020 H.6. INVESTIGATION: BD RECEIVED THE UNIT FROM THE CUSTOMER FOR INVESTIGATION. THE UNIT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR LLO ERROR AND NOISE WITH THE INCIDENT LOT WAS OBSERVED. TO FIX THESE ISSUES THE CAL LEVEL WAS ADJUSTED AND THE PLATE IN THE TUBE COVER WAS REPLACED. 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SEDI-40 INSTRUMENT HAD FREQUENT LLO ERRORS OCCURRING "RANDOMLY" DURING USE, AND "STRANGE NOISES" COULD BE HEARD DURING THE MIXING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. FREQUENT LLO ERROR-THE BLOOD COLLECTION TUBE IS FILLED OVER THE DRAW LINE. THIS ERROR OCCURS RANDOMLY, IT DOES NOT MATTER POSITION IN WHICH TUBE IS PLACED. 2. SOMETIMES CUSTOMER HEARS TRANGE NOICES DIRING MIXING."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ELITECH. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE REPORTED LOT # [00162] WAS NOT FOUND FOR THE REPORTED CATALOG # [36154608]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SEDI-40 INSTRUMENT HAD FREQUENT LLO ERRORS OCCURRING "RANDOMLY" DURING USE, AND "STRANGE NOISES" COULD BE HEARD DURING THE MIXING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. FREQUENT LLO ERROR-THE BLOOD COLLECTION TUBE IS FILLED OVER THE DRAW LINE. THIS ERROR OCCURS RANDOMLY, IT DOES NOT MATTER POSITION IN WHICH TUBE IS PLACED. 2. SOMETIMES CUSTOMER HEAR STRANGE NOICES DIRING MIXING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853336 BD SEDI-40 ESR INSTRUMENT JPH BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other