BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CITRATETUBE

    MDR report key: 7168240 · Received January 5, 2018

    Report

    Report Number
    9617032-2017-00683
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    November 1, 2016
    Report Date
    February 7, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991551
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6159547; MEDICAL DEVICE EXPIRATION DATE: 11/30/2017; DEVICE MANUFACTURE DATE: 6/7/2016. MEDICAL DEVICE LOT #: 6109906; MEDICAL DEVICE EXPIRATION DATE: 10/31/2018; DEVICE MANUFACTURE DATE: 4/18/2016. MEDICAL DEVICE LOT #: 6067917; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 5334625. MEDICAL DEVICE EXPIRATION DATE: 5/31/2017. DEVICE MANUFACTURE DATE: 11/30/2015. MEDICAL DEVICE LOT #: 6089653; MEDICAL DEVICE EXPIRATION DATE: 9/30/2017; DEVICE MANUFACTURE DATE: 3/29/2016. MEDICAL DEVICE LOT #: 6032633; MEDICAL DEVICE EXPIRATION DATE: 8/31/2017; DEVICE MANUFACTURE DATE: 2/1/2016. INVESTIGATION SUMMARY: (B)(4) SAMPLES WERE RECEIVED FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT, AND NO PHOTOGRAPHS WERE ATTACHED. 100 RETURNS WERE FROM LOT NUMBER 6159547 QUOTED IN THE COMPLAINT, AND (B)(4) FROM LOT NUMBER 6067912 NOT QUOTED IN THE COMPLAINT. VISUAL EXAMINATION OF THE 200 RETAINED SAMPLES FROM EACH OF THE IMPLICATED LOT NUMBERS DID NOT IDENTIFY ANY INSTANCES OF DAMAGED TUBES. (B)(4) RETAINED TUBES FROM EACH OF THE (B)(4) LOT NUMBERS WERE TAKEN AND DRAWN WITH HORSE BLOOD. AFTER MIXING, THEY WERE CENTRIFUGED AT 1500G (3000RPM) FOR 15 MINUTES. NONE OF THE (B)(4) TUBES BROKE, AND EXAMINATION OF THEIR RIMS POST CENTRIFUGATION, REVEALED NO SIGNS OF CRACKING. (B)(4) TUBES FROM EACH OF THE TWO RETURNED LOT NUMBERS WERE TESTED IN THE SAME WAY, AGAIN WITH NO BREAKAGES OR DAMAGE RESULTING. INVESTIGATION CONCLUSION: BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE EVALUATION OF THE RETAINED AND RETURNED SAMPLES; ALSO REVIEW OF THE DHRS SHOWED NO INDICATION OF THE ALLEGED DEFECT. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: 11/01/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® CITRATETUBE BROKE IN THE CENTRIFUGE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10753 BD VACUTAINER® CITRATETUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other