BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 12081353 · Received June 28, 2021

    Report

    Report Number
    8041187-2021-00544
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 7, 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

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: H.6. IMDRF ANNEX G GRID : G041901 CANNULA HUB. 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 WHEN USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS FAILURE OF PRODUCT TO CONTAIN BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE NEEDLE HUB WAS FOUND TO BE DAMAGED."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS FAILURE OF PRODUCT TO CONTAIN BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE NEEDLE HUB WAS FOUND TO BE DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976881 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 0275050

    Patients

    Seq Age Sex Outcome Treatment
    1