BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    MDR report key: 8033950 · Received November 2, 2018

    Report

    Report Number
    1917413-2018-03708
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 8, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    05038290363706
    PMA / PMN Number
    K093972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES OF LOT 8191928 FROM THE CUSTOMER FACILITY FOR INVESTIGATION; HOWEVER, SAMPLES FROM INCIDENT LOTS 8096689, 8096684, 7318967 & 7318970 WERE NOT RECEIVED. THE RECEIVED SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR ISSUES WITH THE CAP (LEADING TO LEAKAGE) WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES FOR LOT 8191928 , THE CUSTOMER¿S INDICATED FAILURE MODE FOR ISSUES WITH THE CAP (LEADING TO LEAKAGE) WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. LOT 8191928 WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. AS NO SAMPLES WERE RECEIVED FOR LOTS 8096689, 8096684, 7318967 & 7318970 A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA EXHIBITED STOPPER CREEP OR LOOSE CLOSURE THAT LED TO A LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8191928; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2018-07-10; MEDICAL DEVICE LOT #: 8096689; MEDICAL DEVICE EXPIRATION DATE: 2019-10-31; DEVICE MANUFACTURE DATE: 2018-04-06; MEDICAL DEVICE LOT #: 8096684; MEDICAL DEVICE EXPIRATION DATE: 2019-09-30; DEVICE MANUFACTURE DATE: 2018-04-06; MEDICAL DEVICE LOT #: 7318967; MEDICAL DEVICE EXPIRATION DATE: 2019-05-31; DEVICE MANUFACTURE DATE: 2017-11-14; MEDICAL DEVICE LOT #: 7318970; MEDICAL DEVICE EXPIRATION DATE: 2019-05-31; DEVICE MANUFACTURE DATE: 2017-11-14; MEDICAL DEVICE LOT #: 8191928; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2018-07-10. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA EXHIBITED STOPPER CREEP OR LOOSE CLOSURE THAT LED TO A LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874274 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. SEE H.10 05038290363706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other