BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB

    MDR report key: 8900773 · Received August 16, 2019

    Report

    Report Number
    8041187-2019-00648
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057818
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES OR PHOTOS DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT AND A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW COULD ALSO NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CAPS ARE NOT STAYING ON NEEDLE AND HEATH CARE WORKERS ARE RECEIVING NEEDLE STICK INJURIES WITH A BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3) IT WAS REPORTED THAT THE NEEDLE CAPS ARE NOT STAYING ON SECURELY RESULTING IN NEEDLE STICKS TO STAFF. ADDITIONAL INFORMATION FROM REPORTER: I HAVE HAD MULTIPLE STICKS TO STAFF MEMBERS BECAUSE THE NEEDLE CAPS DO NOT STAY ON SECURELY. THE PACKAGES IS ALSO MORE FRAGILE. WHEN RIPPING THE NEEDLES FROM THE PERFORATED LINES WE TEND TO OPEN THE ACTUAL PACKAGE AND HAVE TO DISCARD THE THEN EXPOSED/NON STERILE NEEDLE. THIS HAS BEEN GOING ON FOR A FEW MONTHS BUT WITH MORE STICKS AND CONVERSATIONS WITH STAFF MEMBERS (MEDICAL ASSISTANTS AND NURSES) I HAVE BEEN MADE AWARE THIS IS A PRETTY CONSISTENT THING.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: UNKNOWN. PMA / 510(K)#: K980987(SYRINGE); K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CAPS ARE NOT STAYING ON NEEDLE AND HEATH CARE WORKERS ARE RECEIVING NEEDLE STICK INJURIES WITH A BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3). IT WAS REPORTED THAT THE NEEDLE CAPS ARE NOT STAYING ON SECURELY RESULTING IN NEEDLE STICKS TO STAFF. ADDITIONAL INFORMATION FROM REPORTER: I HAVE HAD MULTIPLE STICKS TO STAFF MEMBERS BECAUSE THE NEEDLE CAPS DO NOT STAY ON SECURELY. THE PACKAGES IS ALSO MORE FRAGILE. WHEN RIPPING THE NEEDLES FROM THE PERFORATED LINES WE TEND TO OPEN THE ACTUAL PACKAGE AND HAVE TO DISCARD THE THEN EXPOSED/NON STERILE NEEDLE. THIS HAS BEEN GOING ON FOR A FEW MONTHS BUT WITH MORE STICKS AND CONVERSATIONS WITH STAFF MEMBERS (MEDICAL ASSISTANTS AND NURSES) I HAVE BEEN MADE AWARE THIS IS A PRETTY CONSISTENT THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696121 BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN 00382903057818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other