BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER® SST BLOOD COLLECTION TUBES

    MDR report key: 7692878 · Received July 17, 2018

    Report

    Report Number
    2243072-2018-01323
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 5, 2018
    Report Date
    October 1, 2018
    Manufacturer
    BECTON DICKINSON
    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

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, 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 MANUFACTURE: 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 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBE CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    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. 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. 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
    537433 UNSPECIFIED BD VACUTAINER® SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other