Description of Event or Problem · 1
IN 2009, NOVOFINE MFR, NOVO NORDISK INC: I AM WRITING THIS LETTER TO INFORM YOUR COMPANY OF A HAZARD ASSOCIATED WITH THE USE OF YOUR NOVOFINE AUTOCOVER DISPOSABLE SAFETY PEN NEEDLES (LIST: 185275). FOR USE IN THIS LETTER, THE FOLLOWING DEFINITIONS WILL APPLY: "PRIMARY NEEDLE" WILL REFER TO THE NEEDLE COMPONENT OF THE PEN NEEDLE THAT PENETRATES A PT SKIN, "SECONDARY NEEDLE" WILL REFER TO THE PART OF THE NEEDLE COMPONENT WHICH INSERTS INTO THE MEDICATION PEN. THE PEN NEEDLES I AM REFERRING TO ARE THE NOVOFINE AUTOCOVER 30G DISPOSABLE SAFETY NEEDLES. AS A FACILITY REQUIREMENT, MANUFACTURERS MUST PROVIDE ENGINEERING CONTROLS SUCH AS AUTOMATIC LOCKING SAFETY DEVICES INCORPORATED INTO NEEDLE DEVICES OR CREATE NEEDLELESS DEVICES IN ORDER TO PROTECT HEALTHCARE WORKERS. I PURCHASED THE NOVOFINE AUTOCOVER SAFETY PEN NEEDLES IN ORDER TO PROTECT MY HEALTHCARE WORKERS DURING ADMINISTRATION OF MEDICATIONS VIA A MEDICATION PEN. THESE MEDICINES ARE INSULINS AND FORTEO. IN MY FACILITY, ONE RN AND TWO LPNS HAVE OBTAINED NEEDLESTICK INJURIES FROM CONTAMINATED PEN NEEDLES AS A RESULT OF ITS DESIGN. I WILL ADMIT THAT THERE WAS SOME FAULT IN THE PROCEDURE THE NURSES USED WHILE USING THIS DEVICE, BUT A MORE EFFECTIVE SAFETY FEATURE COULD HAVE PREVENTED THESE INJURIES. I WANT TO POINT OUT THAT YOUR SAFETY DEVICE INCORPORATED INTO THE NOVOFINE AUTOCOVER DISPOSABLE SAFETY NEEDLE LOCKS OUT ONLY THE PRIMARY NEEDLE (AS DEFINED IN THE FIRST PARAGRAPH). THE SECONDARY NEEDLE IS NEVER SHIELDED AFTER USE ON A PT. THE SECONDARY NEEDLE IS THE NEEDLE THAT STUCK EACH OF THE THREE NURSES INVOLVED IN THESE CASES. THE INCIDENTS THAT HAVE OCCURRED IN MY FACILITY ARE AS DESCRIBED BELOW. ONE NURSE FOUND A DIRTY NOVOFINE AUTOCOVER SAFETY PEN NEEDLE LYING ON THE FLOOR. THE PRIMARY NEEDLE HAD ITS SAFETY FEATURE ENGAGED AFTER USE AND HAD BEEN SAFELY RECAPPED BY A PREVIOUS NURSE AND AT SOME POINT AFTER ADMINISTRATION LANDED ON THE FLOOR. LATER IN THE EVENING WHEN ANOTHER NURSE (NEEDLESTICK VICTIM) PICKED UP THE NOVOFINE AUTOCOVER SAFETY NEEDLE FROM THE FLOOR, THE SECONDARY NEEDLE PENETRATED HER FINGER. IN A SECOND INCIDENT, A NURSE ADMINISTERED THE PEN MEDICATION VIA THE NOVOFINE AUTOCOVER SAFETY PEN NEEDLE AND THE SAFETY FEATURE ENGAGED ON THE PRIMARY NEEDLE. WHEN SHE WENT TO DISCARD THE NEEDLE, THERE WAS NO SHARPS CONTAINER NEARBY. IN THIS INSTANCE, SHE RECAPPED THE PRIMARY NEEDLE SAFELY, BUT AS SHE TRANSPORTED THE NEEDLE TO A SHARPS CONTAINER, IT ROTATED IN HER HAND AND WAS PINCHED BETWEEN HER THUMB AND INDEX FINGER CAUSING THE SECONDARY NEEDLE TO PRICK HER SKIN. A THIRD INCIDENT OCCURRED WHEN A NURSE WENT TO A PT'S ROOM TO ADMINISTER HER FORTEO MEDICATION VIA A PEN WITH A NOVOFINE AUTOCOVER DISPOSABLE SAFETY NEEDLE ATTACHED. AFTER ADMINISTRATION, THE SAFETY FEATURE ENGAGED, THE NURSE SAFELY USED THE ONE HAND TECHNIQUE TO RECAP THE NEEDLE AND ALSO UPON TRANSPORT TO A SHARPS CONTAINER WAS STUCK BY THE SECONDARY UNSHIELDED NEEDLE. THESE THREE NEEDLESTICKS WERE DEEP ENOUGH TO CAUSE BLOOD TO ERUPT THROUGH THE SKIN. BLOODBORNE PATHOGEN INCIDENTS WERE WRITTEN FOR ALL THREE NURSES/HEALTHCARE WORKERS AND THE NURSES WERE TESTED FOR BLOODBORNE DISEASES AND COUNSELED ABOUT THE EVENTS. WHEN I CONTACTED FACILITY IN REGARD TO THE SIMILARLY OCCURRING INCIDENTS IN ONE FACILITY, THEY REQUESTED THAT I WRITE A LETTER THE MFR TO EXPLAIN THE HAZARD ASSOCIATED WITH THE NOVOFINE AUTOCOVER DISPOSABLE SAFETY NEEDLES. I AM KEEPING THIS LETTER ON FILE AS A DOCUMENT OF FOLLOW-UP FOR THREE SIMILAR NEEDLESTICK ACCIDENTS INVOLVING THE SAME PRODUCT AND WILL SEND A COPY OF THIS LETTER. DIAGNOSIS OR REASON FOR USE: INSULIN OR FORTEO ADMINISTRATION.