BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 8765051 · Received July 5, 2019

    Report

    Report Number
    1917413-2019-01718
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 14, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UNDERFILL WAS NOT UPON COMPLETION, THE ISSUE RELATING TO UNDERFILL 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#260774. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. EVALUATION/TESTING OF THE RETAIN SAMPLES WAS ALSO CONDUCTED AND UNDERFILL WAS OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#260774. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: CAPA#260774 HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES ARE UNDERFILLING. THIS OCCURRED ON 41 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367861, BATCH NO. 8121575 IT WAS REPORTED TUBES WERE WITNESSED AS UNDER FILLING. CASE DETAIL REPORT VERBIAGE, - "TUBES ARE CAUSING SHORT DRAWS. TUBES ARE ONLY FILLING 2/3 FULL."

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 7.2 MG BLOOD COLLECTION TUBES ARE UNDERFILLING. THIS OCCURRED ON 41 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367861, BATCH NO. 8121575. IT WAS REPORTED TUBES WERE WITNESSED AS UNDER FILLING. CASE DETAIL REPORT VERBIAGE, "TUBES ARE CAUSING SHORT DRAWS. TUBES ARE ONLY FILLING 2/3 FULL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559305 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8121575 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other