BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 9535707 · Received December 31, 2019

    Report

    Report Number
    1024879-2019-02200
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 16, 2019
    Report Date
    January 31, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR HUB / COLLAR SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA # 1277214. THE INVESTIGATION IS STILL ON-GOING, AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    MATERIAL NO. 368608, BATCH NO. 9200789. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY & CAP FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER REMOVING THE WHITE CAP END AND ATTEMPTING TO ATTACH TO THE HUB, THE SAFETY AND CAP FALLS OFF. WHEN THE STAFF MEMBER TRIES TO TAKE THE BLACK CAP OFF, THE WHOLE SAFETY AND CAP COME WITH IT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 368608, BATCH NO. 9200789. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY & CAP FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER REMOVING THE WHITE CAP END AND ATTEMPTING TO ATTACH TO THE HUB, THE SAFETY AND CAP FALLS OFF. WHEN THE STAFF MEMBER TRIES TO TAKE THE BLACK CAP OFF, THE WHOLE SAFETY AND CAP COME WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331536 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368608 9200789 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other