BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 11544220 · Received March 22, 2021

    Report

    Report Number
    8041187-2021-00202
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 29, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE SLEEVE FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN OPNEING THE FBN, IT FOUND THE FBN'S SLEEVE'S TAIL WAS FELL OFF."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). 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® FLASHBACK BLOOD COLLECTION NEEDLE SLEEVE FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN OPENING THE FBN, IT FOUND THE FBN'S SLEEVE'S TAIL WAS FELL OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437012 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 0268706

    Patients

    Seq Age Sex Outcome Treatment
    1