BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 10826465 · Received November 11, 2020

    Report

    Report Number
    8041187-2020-00726
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: 11/3/2020. D.4. MEDICAL DEVICE LOT #: 0073711. D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2022. H.4. DEVICE MANUFACTURE DATE: 4/1/2020. H.6. INVESTIGATION: BD RECEIVED 1 SAMPLE FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 NON-CONFORMANCES 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 THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE HAD FOREIGN MATTER ON DEVICE CANNULA / NEEDLE OR ANY FLUID PATH COMPONENT. IT WAS REPORTED DURING USE THE "WHEN OPENING THE PACKAGE, IT FOUND THAT THE NEEDLE HAS FOREIGN MATTER."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN. 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 THE BD VACUTAINER(R) FLASHBACK BLOOD COLLECTION NEEDLE HAD FOREIGN MATTER ON DEVICE CANNULA / NEEDLE OR ANY FLUID PATH COMPONENT. IT WAS REPORTED DURING USE, "WHEN OPENING THE PACKAGE, IT FOUND THAT THE NEEDLE HAS FOREIGN MATTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288668 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON MEDICAL (SINGAPORE) 0073711

    Patients

    Seq Age Sex Outcome Treatment
    1