Description of Event or Problem · 1
A DEFECTIVE SYRINGE FROM THE BLOOD THINNER LOVENOX, USED IN ACCORDANCE WITH PACKAGE DIRECTIONS, HAD THE NEEDLE CAP INITIALLY STICK, THEN SUDDENLY BREAK LOOSE WITH CONSIDERABLE FORCE. THE SINGLE DEFECTIVE SYRINGE ACTUALLY CAUSED TWO SEPARATE INJURIES, PLASTIC CAP SHOT WITH FORCE INTO RIGHT PALM CAUSING A HEMATOMA. THE SYRINGE CAME TO REST STICKING OUT OF MY RIGHT THUMB. PARTS -1- AND -2- OF THIS INJURY ARE DETAILED BELOW AS WELL AS OUTCOME AND TREATMENT TO DATE. THE PLASTIC NEEDLE CAP ESSENTIALLY "FIRED" AS IF A PLASTIC BULLET SHOT AT CLOSE RANGE INTO MY RIGHT PALM. THIS RESULTED IN A HEMATOMA WHICH SEEMS RESOLVED AND WHAT DOCTORS HAVE BEEN CALLING A "TORN LIGAMENT" ON THE BACK OF THE RIGHT HAND LIKELY FROM THE IMPACT TO THE RIGHT PALM. THE FORCE OF THIS IMPACT WAS VERY PAINFUL AND RESULTED IN ME NOT BEING SURE HOW THE SECOND PART OCCURRED. SOMEHOW THE SYRINGE WITH THE NEEDLE ENDED UP STICKING STRAIGHT OUT OF MY RIGHT THUMB. WHEN I TRIED TO REMOVE THE SYRINGE, THE NEEDLE BROKE OFF IN MY THUMB AND LEFT ENOUGH STICKING OUT OF MY THUMB TO PULL IT OUT. THE REMAINING APPROXIMATELY 1/8 INCH IS STILL STICKING OUT OF THE LOVENOX SYRINGE WHICH I STILL HAVE. THE LOVENOX ITSELF REMAINS IN THE SYRINGE. THIS WAS MY MORNING INJECTION AROUND 10 AM AND WHILE THE HAND WAS SOMEWHAT PAINFUL, I SEEMED OKAY. I EVEN GAVE MY EVENING INJECTION OF LOVENOX THE SAME DAY WITHOUT INCIDENT THOUGH MY HAND WAS QUITE SORE AND A BIT SWELLED. AT 3 AM, SO ABOUT 15 HOURS AFTER THE INCIDENT, MY RIGHT HAND BECAME VERY PAINFUL, AND INCREASINGLY RED AND SWOLLEN. I WENT TO THE EMERGENCY ROOM AROUND 10 AM AND THE HAND CONTINUED TO BE INCREASINGLY PAINFUL AND SHOW ADDITIONAL SIGNS OF INFECTION. I WAS ULTIMATELY ADMITTED TO (B)(6) HOSPITAL AND WAS ON IV VANCOMYCIN FOR 10 DAYS AND ORAL CIPRO FOR A TOTAL OF 14 DAYS. THIS INJURY WAS IN MY DOMINANT - RIGHT- HAND AND I WAS UNABLE TO DO ANY FORM OF SELF CARE INCLUDING INJECT LOVENOX OR MUCH OF ANYTHING ELSE. I SPENT 11 DAYS IN THE HOSPITAL FOLLOWED BY 4 DAYS IN A POST ACUTE FACILITY. WHEN I WAS ABLE TO GIVE MYSELF TWO SUCCESSIVE LOVENOX INJECTIONS, I WAS PERMITTED TO GO HOME. AS OF TODAY, (B)(6) 2011, I AM STILL EXPERIENCING SWELLING AND LIMITED USE OF MY RIGHT HAND. THERE IS A RAISED AREA BETWEEN THE KNUCKLE BETWEEN THE INDEX AND MIDDLE FINGERS. WHEN I WAS BACK TO SEE MY PRIMARY PHYSICIAN THIS WEEK FOR FOLLOW UP, SHE TOOK ONE LOOK AT IT AND SAID SHE FELT IT WILL NEED SURGERY, HOWEVER, THE ORTHOPEDIC SPECIALIST WHO LOOKED AT THE INJURY SEVERAL TIMES SAID THAT WHILE SHE FEELS THERE IS A TORN LIGAMENT AND SURGERY COULD REPAIR IT, THE LOCATION AND MY OWN HISTORY MAKE SCARRING LIKELY. THEREFORE, SURGERY SEEMS UNLIKELY AND EVIDENTLY THIS IS GOING TO BE A LIFE LONG PROBLEM. AT THIS POINT, I HAVE NOTED THAT MY TYPING SPEED IS SLOWED FROM PREVIOUSLY DOCUMENTED LONG STANDING 35 WORDS PER MINUTE TO 21 WORDS PER MINUTE AND I HAVE DIFFICULTY NEGOTIATING A COMPUTER MOUSE AND DIFFICULTY CUTTING UP FOOD WITH A STEAK KNIFE. I HAVE BEEN INCREASINGLY USING MY LEFT HAND FOR THINGS I USED TO DO WITH THE RIGHT HAND AND I FEAR THIS WILL HAVE LIFELONG IMPACT. IT IS PARTICULARLY FRUSTRATING TO ME THAT I HAVE CALLED LOVENOX IN THE PAST AT LEAST TWICE ABOUT CONCERNS OVER DIFFICULT TO REMOVE CAPS AND ALSO TWO PRIOR NEEDLE STICK INJURIES THAT DID NOT HAVE SUCH SEVERE RESULTS. I HAVE ALSO HAD AT LEAST TWO SYRINGES IN MY ROUGHLY THREE YEAR PERIOD OF USE THAT FAILED TO DISCHARGE THE MEDICATION AFTER THE NEEDLE WAS INSERTED. IN MY OPINION, THIS IS A DANGEROUS PRODUCT DESIGN AND THE TYPE OF INJURY I EXPERIENCED WOULD HAVE HAPPENED TO SOMEONE EVENTUALLY. THE DIRECTIONS FOR USING THIS PRODUCT ARE RIDICULOUS SINCE THE SHOW SOMEONE IN DRAWINGS HOLDING THE SYRINGE, SO A CAP THAT STICKS AS THIS ONE DID CAN BE FULLY EXPECTED TO CAUSE THIS SORT OF INJURY. I HAVE TOLD SANOFI-AVENTIS THIS REPEATEDLY, BUT THEY DON'T SEEM TO BE LISTENING. THE FIRST SANOFI-AVENTIS EMPLOYEE I SPOKE TO WHEN I WAS INJURED ACTUALLY FOUND THIS AMUSING, BUT AT THAT TIME, I HADN'T DEVELOPED THE INFECTION. I WAS ALSO SHARING MY CONCERN THAT THE NEEDLE SHIELD IS DIFFICULT TO ENGAGE ON SOME SYRINGES. FOR (B)(6) A DOSE, I FEEL THAT THEY SHOULD AT LEAST PROVIDE A SYRINGE THAT FUNCTIONS MORE RELIABLY. DOSE: 120 MG, EVERY 12 HOURS SQ. DATES OF USE: LIFETIME USE BEGAN 2008. DIAGNOSIS OR REASON FOR USE: FIVE PREVIOUS PULMONARY EMBOLI, COUMADIN FAILURE.