BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 13177795 · Received January 6, 2022

    Report

    Report Number
    8041187-2021-01096
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 9, 2021
    Report Date
    January 7, 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 #: 1113063. MEDICAL DEVICE EXPIRATION DATE: 04/30/2023. DEVICE MANUFACTURE DATE: 04/30/2021. MEDICAL DEVICE LOT #: 0324844. MEDICAL DEVICE EXPIRATION DATE: 11/30/2022. DEVICE MANUFACTURE DATE: 11/30/2020. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/21/2021. H.6. INVESTIGATION: BD RECEIVED 3 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. A RED FOREIGN MATTER CAN BE SEEN IN THE FLASHBACK CHAMBER OF ALL 3 FLASHBACK NEEDLES (FBN'S). ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. THE RED FOREIGN MATTER WAS OBSERVED IN THE FLASHBACK CHAMBER, THE IV CANNULA, AND ALSO THE NP CANNULA ON ALL 3 RETURNED SAMPLES. PUNCTURED MARKS WERE ALSO OBSERVED ON THE RUBBER SLEEVE TIPS. ONE OF THE SAMPLES WAS SENT FOR FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING AND THE RESULTS SHOW THAT THE RED FOREIGN MATTER IS A PROTEIN. 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 MODE FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. ONLY GREEN LIQUID IS USED TO TEST FBN'S AT THE MANUFACTURING SITE.

    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 #: 1113063. MEDICAL DEVICE EXPIRATION DATE: 04/30/2023. DEVICE MANUFACTURE DATE: 04/30/2021. MEDICAL DEVICE LOT #: 0324844. MEDICAL DEVICE EXPIRATION DATE: 11/30/2022. DEVICE MANUFACTURE DATE: 11/30/2020. 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE PATIENT WAS PUNCTURED, THE NURSE FOUND AN OBVIOUS FOREIGN BODY IN THE FLASHBACK WINDOW AFTER OPENING THE NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE PATIENT WAS PUNCTURED, THE NURSE FOUND AN OBVIOUS FOREIGN BODY IN THE FLASHBACK WINDOW AFTER OPENING THE NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE PATIENT WAS PUNCTURED, THE NURSE FOUND AN OBVIOUS FOREIGN BODY IN THE FLASHBACK WINDOW AFTER OPENING THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57422 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