BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER® SST BLOOD COLLECTION TUBES

    MDR report key: 7692872 · Received July 16, 2018

    Report

    Report Number
    2243072-2018-01319
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 5, 2018
    Report Date
    December 20, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW.

    Additional Manufacturer Narrative · 0

    BD INTERNAL COMMENTS STATE THE PLANT NUMBER/DESCRIPTION IN THE PRODUCT INFORMATION TABLE WAS CORRECTED. (B)(4).

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD VACUTAINER® SST BLOOD COLLECTION TUBES WERE "PARTIALLY SPUN OR UNSPUN." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD VACUTAINER SST BLOOD COLLECTION TUBES WERE "PARTIALLY SPUN OR UNSPUN." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD VACUTAINER SST BLOOD COLLECTION TUBES WERE "PARTIALLY SPUN OR UNSPUN." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD VACUTAINER® SST BLOOD COLLECTION TUBES WERE "PARTIALLY SPUN OR UNSPUN." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530981 UNSPECIFIED BD VACUTAINER® SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other