BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG

    MDR report key: 8565547 · Received April 30, 2019

    Report

    Report Number
    1917413-2019-01402
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903675871
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOTS AND, BASED ON THIS REVIEW, 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT 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 WHILE ASPIRATING THE BLOOD IN THE BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG TUBE, THE VOLUME COLLECTED WAS NOTICED TO BE LESS THAN THE VOLUME DESCRIBED WITHIN THE TUBE. LOT # 7340866 WAS REPORTED TO HAVE 1 OCCURRENCE OF THE EVENT, WHILE LOT # 8121553 WAS REPORTED TO HAVE HAD AN UNKNOWN NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "IT WAS REPORTED BY THE PROFESSIONALS THAT THE FLUORIDE TUBES WERE ASPIRATING AN UNDERFILL VOLUME. WHEN ASPIRATING THE BLOOD IT WAS NOTED THAT THE VACUUM IS OVER AND THE VOLUME COLLECTED IS LESS THAN THE VOLUME DESCRIBED IN THE TUBE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7340866, MEDICAL DEVICE EXPIRATION DATE: 2019-04-30, DEVICE MANUFACTURE DATE: 2017-12-06. MEDICAL DEVICE LOT #: 8121553, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2018-05-01. DEVICE EVALUATED BY MFR: 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 WHILE ASPIRATING THE BLOOD IN THE BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG TUBE, THE VOLUME COLLECTED WAS NOTICED TO BE LESS THAN THE VOLUME DESCRIBED WITHIN THE TUBE. LOT # 7340866 WAS REPORTED TO HAVE 1 OCCURRENCE OF THE EVENT, WHILE LOT # 8121553 WAS REPORTED TO HAVE HAD AN UNKNOWN NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE PROFESSIONALS THAT THE FLUORIDE TUBES WERE ASPIRATING AN UNDERFILL VOLUME. WHEN ASPIRATING THE BLOOD IT WAS NOTED THAT THE VACUUM IS OVER AND THE VOLUME COLLECTED IS LESS THAN THE VOLUME DESCRIBED IN THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358668 BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE SECTION H.10. 50382903675871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other