BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 25X1 RB

    MDR report key: 10872268 · Received November 19, 2020

    Report

    Report Number
    8041187-2020-00765
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE CANNULA WAS OBSERVED TO BENT AT THE TOP OF THE EPOXY AND THE SAFETY SHIELD WAS ABSENT. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE DEVICE HISTORY RECORD REVIEW, NO ABNORMALITIES WERE OBSERVED DURING THE PRODUCTION OF THE AFFECTED MOLDING, ASSEMBLED NEEDLE, BULK ASSEMBLED NEEDLE AND PACKAGED NEEDLE BATCHES. THE RECEIVED PHOTO SHOWS THE CANNULA WAS BENT AT THE TOP OF THE EPOXY WHICH IS LIKELY DUE TO PRODUCT APPLICATION. AS NO SAMPLE WAS RETURNED TO INVESTIGATE FURTHER AND NO ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE ECLIPSE 25X1 RB HAD BROKEN SAFETY MECHANISMS AND DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SAFEGUARD DOES NOT WORK/ NEEDLE IS DULL CAUSING PAIN/ RESISTANCE IS PRESENT, PUSH HARD WHEN GIVING VACCINES. EMAIL VERBATIM: "ALL STAFF IN IM COMPLAINT ABOUT THE ONLY NEEDLE FOR ADMIN VACCINES TO PATIENTS BD ECLIPSE NEEDLE 25 GAUGE 1 INCH LOT 0143247 WE DON'T FEEL IT IS SAFE TO ADMINISTER VACCINES WITH THIS SAFEGUARD DOES NOT WORK NEEDLE IS DULL CAUSING PAIN RESISTANCE IS PRESENT, PUSH HARD WHEN GIVING VACCINES STAFF DOESN'T WANT TO USE THIS, NO ALTERNATIVE" MY TEAM DOES USE A DIFFERENT NEEDLE TO DRAW UP WITH. I THINK THEY ARE CONCERNED IN GENERAL WITH SAFETY AS THEY SEEM FLIMSY AND BEND EASILY. AS FAR AS THE SAFEGUARD GOES, I HAVE FEEDBACK THAT THE SAFEGUARD HAS FALLEN OFF AND THEN THE NEEDLE BENDS. ONE OF MY TEAM MEMBERS IS GOING TO SEND ME THE PICTURE AS SHE THREW THE SYRINGE OUT. I WILL FORWARD IT TO YOU."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE ECLIPSE 25X1 RB HAD BROKEN SAFETY MECHANISMS AND DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SAFEGUARD DOES NOT WORK/ NEEDLE IS DULL CAUSING PAIN/ RESISTANCE IS PRESENT, PUSH HARD WHEN GIVING VACCINES. EMAIL VERBATIM: "ALL STAFF IN IM COMPLAINT ABOUT THE ONLY NEEDLE FOR ADMIN VACCINES TO PATIENTS BD ECLIPSE NEEDLE 25 GAUGE 1 INCH. LOT 0143247. WE DON'T FEEL IT IS SAFE TO ADMINISTER VACCINES WITH THIS SAFEGUARD DOES NOT WORK. NEEDLE IS DULL CAUSING PAIN. RESISTANCE IS PRESENT, PUSH HARD WHEN GIVING VACCINES. STAFF DOESN'T WANT TO USE THIS, NO ALTERNATIVE" MY TEAM DOES USE A DIFFERENT NEEDLE TO DRAW UP WITH. I THINK THEY ARE CONCERNED IN GENERAL WITH SAFETY AS THEY SEEM FLIMSY AND BEND EASILY. AS FAR AS THE SAFEGUARD GOES, I HAVE FEEDBACK THAT THE SAFEGUARD HAS FALLEN OFF AND THEN THE NEEDLE BENDS. ONE OF MY TEAM MEMBERS IS GOING TO SEND ME THE PICTURE AS SHE THREW THE SYRINGE OUT. I WILL FORWARD IT TO YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330838 NEEDLE ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305761 0143247 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1