Description of Event or Problem · 0
DEAR FDA, DEFECTIVE DEVICE DEPARTMENT I'VE BEEN USING THE INJECT-EASE DEVICE FOR ABOUT 2 1/1 YEARS NOW FOR ED. I'VE ALWAYS HAD A PROBLEM WITH THE DEVICE AS YOU CAN SEE BELOW, AND I'M SURE OTHERS HAVE AS WELL. I'VE BEEN IN CLOSE CONTACT WITH THE MANUFACTURER OVER THE LAST 3 MONTHS TO TRY AND CORRECT THIS. THEY HAVE SENT ME 2 OR 3 REPLACEMENT TIPS AND THEY ARE ALL DEFECTIVE. MY GUESS IS THEY ARE BEING MADE IN CHINA AS THEIR QUALITY CONTROL IS LOUSY AND THEY'RE ALL BAD. I JUST RECEIVED ANOTHER TIP THAT (B)(6) PROMISED ME IS FINE, AND IT TOO IS HORRIBLE. THEY KEEP TELLING ME THE PROBLEM HAS BEEN FIXED, BUT THEY DON'T KNOW WHAT THEY ARE DOING. I'M NOT HERE TO GET ANYONE IN TROUBLE, THEY ARE RESPONSIVE AND PROMPT, JUST CLUELESS. I'M POSITIVE OTHER CUSTOMERS ARE HAVING MY SAME EXPERIENCE AS I AM. AMBIMEDINC NEEDS TO FIX THIS PROBLEM NOW BEFORE MORE PEOPLE ARE POSSIBLY HURT. BELOW IS SOME OF MY CORRESPONDENCE WITH THEM, SINCE THEN THERE HAVE BEEN MANY COMMUNICATIONS, BUT NONE IF IT IS HELPING SOLVE THIS PROBLEM. DEAR AMBIMEDINC, I'VE BEEN A USER OF YOUR INJECT-EASE INJECTOR FOR ABOUT TWO+ YEARS. I PURCHASED THE INJECTOR FROM (B)(6) IN (B)(6) AND HAVE HAD SOME TROUBLE WITH IT EVER SINCE. TODAY I WAS INJECTING TRIMIX #8 FOR MY ED, AND AS I REMOVED THE INJECTOR, I FELT LIQUID AT THE SITE AND THE 90 DEGREE BENT NEEDLE NICKED ME AS I REMOVED THE INJECTOR. OVER THE LAST TWO YEARS, THIS HAS HAPPENED FOUR OR FIVE TIMES. THE NEEDLE BENDS HORRIBLY, AND I'VE BEEN INCORRECTLY BLAMING THIS ON DEFECTIVE NEEDLES. TODAY WAS DIFFERENT. I INSPECTED THE NEEDLE CAREFULLY BEFORE INJECTION, AND IT WAS IN PERFECT CONDITION. BECAUSE THIS KEEPS HAPPENING, I THEN DIRECTED MY ATTENTION TO THE INJECTOR NOSECONE. UPON LOOKING CLOSELY WITH A MAGNIFYING GLASS, I COULD SEE THAT ABOUT A THIRD OF THE INNER DIAMETER, ABOUT A 16TH OF AN INCH FROM THE TIP, WAS A PROMINENT RIDGE. NOT A LOT, BUT ENOUGH TO CATCH THE NEEDLE TIP AS IT FLIES FORWARD. THE INNER DIAMETER IS OUT OF CONCENTRIC AND WAS NOT FINISHED CORRECTLY. BEING A FIX-IT GUY, AND NOT WANTING THE DAY TO GO TO WASTE, I CAREFULLY CARVED OUT THE RIDGE WITH A SHARP EXACTO KNIFE, AND THEN POLISHED OUT THE INNER DIAMETER DAMAGE WITH 400X WET/DRY SANDPAPER, AND CONTINUED UP TO 1500X. IT NOW WORKS CORRECTLY, BUT I'M VERY UNHAPPY TO HAVE BEEN FORCED TO MODIFY AN OBVIOUSLY DEFECTIVE MEDICAL DEVICE. THE DEFECT IS GLARING. SO MUCH SO, I'M 100% SURE I'M NOT THE ONLY ONE THIS IS HAPPENING TO. MOST PEOPLE ARE PROBABLY BLAMING THE NEEDLE LIKE I WAS, THE PROBLEM IS THE DEFECTIVE NOSECONE. RUN A POINTED TEST TOOL UP THROUGH THE TIP (EVEN A STRAIGHTENED OUT PAPERCLIP) AND YOU'LL SEE HOW IT CAN CATCH A NEEDLE TIP AS IT'S FLYING FORWARD. THE NEEDLE HAS TO HIT IT JUST RIGHT. DOES THE SHARP TIP HIT THE RIDGE? THAT WILL EXPLODE THE NEEDLE EVERY TIME. OR DOES THE BACK OF THE NEEDLE TIP HIT THE RIDGE? THAT MAY SKIM OVER THE COLLISION. DOES THE NEEDLE PASS THE TIP WHERE THERE IS NO FLASH? IT WILL SURVIVE THERE. IF THE NEEDLE IS SEATED IN THE CENTER... NO PROBLEM. IT'S ONLY WHEN THE NEEDLE IS COCKED TO THE SIDE JUST RIGHT THAT IT CAN HIT THE RIDGE AND BEND. LOOK AT ME, IT TOOK ME TWO YEARS AND MANY FAILURES TO FINALLY REALIZE IT WAS THE INJECTOR'S FAULT, NOT A BAD NEEDLE. MY NAME IS (B)(6). PT CODE: 2462. DEVICE CODES: 2981, 4013. REF REPORT: MW5180002.