BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE WITH DETACHABLE BD ECLIPSE NEEDLE

    MDR report key: 10551614 · Received September 17, 2020

    Report

    Report Number
    8041187-2020-00586
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057895
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE SAFETY SHIELD BROKE WHEN ENGAGED AFTER USE, LEAVING THE NEEDLE EXPOSED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE (REF 305789), PLUS OTHERS WHO HAVE EXPRESSED CONCERNS BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED. THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED. THE SHIELD FELL OFF".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: PISTON SYRINGE, MEDICAL DEVICE TYPE: FMF. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K941562 (SYRINGE), PMA / 510(K)#: 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE SAFETY SHIELD BROKE WHEN ENGAGED AFTER USE, LEAVING THE NEEDLE EXPOSED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE (REF 305789), PLUS OTHERS WHO HAVE EXPRESSED CONCERNS BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED. THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED. THE SHIELD FELL OFF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016105 BD LUER-LOK SYRINGE WITH DETACHABLE BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305789 UNKNOWN 30382903057895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other