BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 11097463 · Received December 30, 2020

    Report

    Report Number
    1024879-2020-00973
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 7, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: 1/19/2021. H.6. INVESTIGATION: BD RECEIVED 2 SHELF PACK OF SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DIFFICULT TO ACTIVATE WITH THE INCIDENT LOT WAS OBSERVED. (B)(4) SAMPLES FROM LOT 0232081 WERE TESTED, (B)(4) SAMPLES HAD NO DEFECTS OBSERVED WHILE (B)(4) SAMPLES APPEARED TO HAVE SLANTED IV NEEDLES. IN ADDITION, (B)(4) SAMPLES FROM LOT 0203836 WERE TESTED, OF THE SAMPLES HAD NO DEFECTS WHILE SAMPLE APPEARED TO HAVE A SLANTED NEEDLE. BD DETERMINED THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO BENT NEEDLES RECEIVED FROM THE SUPPLIER. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY SHIELD BROKE OFF AFTER ACTIVATION WITH 5 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PINK ECLIPSE NEXT TO THE NEEDLE AFTER ACTIVATION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD BROKE OFF AFTER ACTIVATION WITH 5 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PINK ECLIPSE NEXT TO THE NEEDLE AFTER ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563436 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 0232081

    Patients

    Seq Age Sex Outcome Treatment
    1