BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 11335380 · Received February 16, 2021

    Report

    Report Number
    8041187-2021-00099
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057870
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K)#: AN ADDITIONAL PMA/510(K) APPLIES TO THE NEEDLE COMPONENT OF THE DEVICE AS: K161170. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE" NEEDLE EXPERIENCED ISSUES WITH THE SYRINGE VOLUMETRIC ACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305787, BATCH NO.: 7356262. CAPTAIN IN (B)(6) RECEIVED COVID VACCINE KITS CONTAINING THE ECLIPSE NEEDLE. HIS STAFF NOTED THAT USING THIS NEEDLE THEY COULD ONLY DRAW UP 10 VACCINES. THEY DECIDED TO TRY USING THE INTEGRA SYRINGE/NEEDLE COMBO AND ARE ABLE TO DRAW UP TO 11 OR MORE VACCINES TO ADMINISTER AND CALLER IS LOOKING FOR ANSWERS. INFORMED THAT WE ARE HAVING A MEDICAL AFFAIRS MEETING THIS AFTER NOON REGARDING THE NEEDLES IN THE MODERNA KITS. I WILL INFORM THEM OF THIS INFORMATION AS WELL. CUSTOMER STATED THAT THE KITS THEY ARE RECEIVING COME WITH MULTI-DOSE VIALS THAT DO NOT REQUIRE RECONSTITUTION. AT SOME POINT THEY REALIZED THAT THEY WERE GOING TO RUN OUT OF ECLIPSE SYRINGES AND STARTED USING INTEGRA SYRINGES. THAT IS WHEN THEY NOTICED THAT THEY COULD ADMINISTER MORE VACCINES. CALLER STATES THAT HE JUST SPOKE WITH VACCINE MANUFACTURER AND WAS TOLD THAT THE VACCINE VIALS CONTAIN 6.3ML WHICH ALLOW FOR 2 EXTRA DOSES, AND SOME CONTAIN 6.5ML WHICH ALLOW FOR 3 EXTRA DOSES. THE VIALS WERE VISUALLY COMPARED AND NOTED THAT SOME HAD MORE SOLUTION IN THEM THAN OTHERS. THE ECLIPSE NEEDLE IN THE KIT IS (3ML X 25G X 1") 305787 WITH LOT 7356262. THE INTEGRA SYRINGE USED IS (3ML X 23G X 1") 305271 WITH LOT 0002375.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE" NEEDLE EXPERIENCED ISSUES WITH THE SYRINGE VOLUMETRIC ACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305787 BATCH NO.: 7356262 CAPTAIN IN AIR FORCE RECEIVED COVID VACCINE KITS CONTAINING THE ECLIPSE NEEDLE. HIS STAFF NOTED THAT USING THIS NEEDLE THEY COULD ONLY DRAW UP 10 VACCINES. THEY DECIDED TO TRY USING THE INTEGRA SYRINGE/NEEDLE COMBO AND ARE ABLE TO DRAW UP TO 11 OR MORE VACCINES TO ADMINISTER AND CALLER IS LOOKING FOR ANSWERS. INFORMED THAT WE ARE HAVING A MEDICAL AFFAIRS MEETING THIS AFTER NOON REGARDING THE NEEDLES IN THE MODERNA KITS. I WILL INFORM THEM OF THIS INFORMATION AS WELL. CUSTOMER STATED THAT THE KITS THEY ARE RECEIVING COME WITH MULTI-DOSE VIALS THAT DO NOT REQUIRE RECONSTITUTION. AT SOME POINT THEY REALIZED THAT THEY WERE GOING TO RUN OUT OF ECLIPSE SYRINGES AND STARTED USING INTEGRA SYRINGES. THAT IS WHEN THEY NOTICED THAT THEY COULD ADMINISTER MORE VACCINES. CALLER STATES THAT HE JUST SPOKE WITH VACCINE MANUFACTURER AND WAS TOLD THAT THE VACCINE VIALS CONTAIN 6.3ML WHICH ALLOW FOR 2 EXTRA DOSES, AND SOME CONTAIN 6.5ML WHICH ALLOW FOR 3 EXTRA DOSES. THE VIALS WERE VISUALLY COMPARED AND NOTED THAT SOME HAD MORE SOLUTION IN THEM THAN OTHERS. THE ECLIPSE NEEDLE IN THE KIT IS (3ML X 25G X 1") 305787 WITH LOT 7356262. THE INTEGRA SYRINGE USED IS (3ML X 23G X 1") 305271 WITH LOT 0002375.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228998 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7356262 00382903057870

    Patients

    Seq Age Sex Outcome Treatment
    1