BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 13997971 · Received April 4, 2022

    Report

    Report Number
    8041187-2022-00167
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 16, 2022
    Report Date
    March 21, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1232755. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2021-09-16. MEDICAL DEVICE LOT #: 1214110. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2021-09-16. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 5 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR MISSING UNIT LABEL, HOOKED NEEDLE POINT, AND FOREIGN MATTER WERE OBSERVED. THE FAILURE MODE OF LOOSE CANNULA WAS NOT OBSERVED FROM THE PHOTOS. 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES MISSING UNIT LABEL, HOOKED NEEDLE POINT, AND FOREIGN MATTER. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE FAILURE MODE LOOSE CANNULA. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE MISSING UNIT LABEL OR THE FOREIGN MATTER. BD DETERMINED THAT THE ROOT CAUSE OF THE HOOKED NEEDLE POINT WAS ATTRIBUTED TO THE MANUFACTURING PROCESS AND CORRECTIVE ACTIONS HAVE BEEN MADE TO HELP PREVENT HOOKED NEEDLE POINTS. THIS COMPLAINT LOT HAS BEEN MANUFACTURED BEFORE COMPLETION OF THESE CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS FOREIGN MATTER IN THE TUBE, NO LABEL OR MISSING LABEL INFORMATION, AND NON PATIENT NEEDLE SEPARATION FROM THE HOLDER HUB. THE LOOSE CANNULA EVENT OCCURRED 2 TIMES. THE FOREIGN MATTER EVENT OCCURRED 2 TIMES. THE MISSING LABEL EVENT OCCURRED 1 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE BLOOD COLLECTION NEEDLE WAS FOUND TO HAVE THE FOLLOWING DEFECTS: FOREIGN MATTER OUTSIDE THE NEEDLE TIP, THE NEEDLE HAD FALLEN OFF AND THERE WAS A MISSING LABEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941056 BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown