BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER BLOOD COLLECTION NEEDLE CE

    MDR report key: 11031698 · Received December 17, 2020

    Report

    Report Number
    9617032-2020-01056
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 27, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/6/2021. H.6. INVESTIGATION: BD RECEIVED 6 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR BROKEN OFF CANULA WITH THE INCIDENT LOT WAS OBSERVED, IN ONE OF THE SAMPLES. UPON EVALUATION OF THE STEP BY STEP GUIDE FOR THIS MSN NEEDLE, IT IS ADVISED TO USE THE TOURNIQUET AND THE DRAWING SHOWS THE HUMAN ARM. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® BLOOD COLLECTION NEEDLE CE THE CANNULA BROKE OFF IN VEIN OF A EWE. ULTRASOUND WAS DONE AND THE CANNULA WAS NOT DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENTLY WE HAD AN ACCIDENT WITH A BD VACUTAINER NEEDLE. AS A STUDENT INTRODUCED THE NEEDLE INTO THE JUGULAR VEIN ON A EWE IT BROKE OFF. THERE WAS NO INDICATION OF ANY DIFFICULT REDIRECTION OR STRUGGLING FROM THE EWE. INITIALLY WE COULD FEEL IT BUT UPON FURTHER INVESTIGATION WITH AN ULTRASOUND WE WERE NOT ABLE TO LOCATE IT AND REMOVE IT. THIS OCCURRED ON (B)(6). TO MY KNOWLEDGE THE EWE IS DOING ALRIGHT BUT WE HAVE MARKED HER IN THE FLOCK TO KEEP AN EYE ON HER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® BLOOD COLLECTION NEEDLE CE THE CANNULA BROKE OFF IN VEIN OF A EWE. ULTRASOUND WAS DONE AND THE CANNULA WAS NOT DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENTLY WE HAD AN ACCIDENT WITH A BD VACUTAINER NEEDLE. AS A STUDENT INTRODUCED THE NEEDLE INTO THE JUGULAR VEIN ON A EWE IT BROKE OFF. THERE WAS NO INDICATION OF ANY DIFFICULT REDIRECTION OR STRUGGLING FROM THE EWE. INITIALLY WE COULD FEEL IT BUT UPON FURTHER INVESTIGATION WITH AN ULTRASOUND WE WERE NOT ABLE TO LOCATE IT AND REMOVE IT. THIS OCCURRED ON NOVEMBER 27TH. TO MY KNOWLEDGE THE EWE IS DOING ALRIGHT BUT WE HAVE MARKED HER IN THE FLOCK TO KEEP AN EYE ON HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491347 BD VACUTAINER BLOOD COLLECTION NEEDLE CE HYPDERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 9108548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other