BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    MDR report key: 9075464 · Received September 17, 2019

    Report

    Report Number
    1917413-2019-02082
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    July 22, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR DAMAGE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER AND INCORRECT COUNT WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, 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 8 ABBOTT TUBES EDTA PLH 13X75 2.0 PNK HAD DAMAGED PACKAGING, 18 TUBES HAD DAMAGED UNIT LABELS, 4 TUBES HAD DAMAGED STOPPERS, 1 TUBE HAD FOREIGN "DIRT" INSIDE IT, 1 TUBE HAD FOREIGN MATTER ON THE STOPPER, AND 1 TUBE HAD FOREIGN MATTER INSIDE IT. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9128795. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE A LIST OF COMPLAINTS FOR BD CAT NUMBER 364676 LOT NUMBER 9128795. "IT IS REPORTED TUBES HAD DIRT AND DEBRIS ON THEM AS WELL AS "BAD CAPS AND LABELS". ALSO CUSTOMER REPORTED DAMAGED SHRINK WRAP AND INCORRECT COUNT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K070820. PMA / 510(K)#: K070822. PMA / 510(K)#: K080751. 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 8 ABBOTT TUBES EDTA PLH 13X75 2.0 PNK HAD DAMAGED PACKAGING, 18 TUBES HAD DAMAGED UNIT LABELS, 4 TUBES HAD DAMAGED STOPPERS, 1 TUBE HAD FOREIGN "DIRT" INSIDE IT, 1 TUBE HAD FOREIGN MATTER ON THE STOPPER, AND 1 TUBE HAD FOREIGN MATTER INSIDE IT. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9128795. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE A LIST OF COMPLAINTS FOR BD CAT NUMBER 364676 LOT NUMBER 9128795. "IT IS REPORTED TUBES HAD DIRT AND DEBRIS ON THEM AS WELL AS "BAD CAPS AND LABELS". ALSO CUSTOMER REPORTED DAMAGED SHRINK WRAP AND INCORRECT COUNT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872753 ABBOTT TUBE EDTA PLH 13X75 2.0 PNK BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9128795

    Patients

    Seq Age Sex Outcome Treatment
    1 Other