Description of Event or Problem · 1
BEGINNING IN 2008, AND OVER THE LAST TWO WEEKS, WE HAVE DISCOVERED FAULTY PACKAGING FOR A NUMBER OF DIFFERENT KINGLI ACUPUNCTURE NEEDLES, COMPROMISING STERILITY AND CREATING A POTENTIAL HAZARD FOR PRACTIONERS. ALTHOUGH THE INITIAL DISCOVERY WAS RESTRICTED TO PACKAGES THAT CONTAINED 5 ACUPUNCTURE NEEDLES. WE HAVE SUBSEQUENTLY FOUND THE SAME ISSUE WITH A FEW SINGLE NEEDLE KINGLI PACKAGES, AS WELL AS WITH ANOTHER MFR - ACUTEK. WE ALSO FOUND TWO DIFFERENT INSTANCES WHERE IT APPEARS THAT A STRAND OF HAIR WAS SEALED IN THE "STERILE" KINGLI PACKAGE. THE PRINCIPLE ISSUE FOUND IS THAT IN MANY INSTANCES, THE TIPS OF THE NEEDLES HAVE PENETRATED THE PLASTIC RETAINING SHEATH, AND PROTRUDE FROM THE PACKAGE COMPROMISING BOTH STERILITY, AND CREATING THE NEEDLE STICK HAZARD. WE HAVE FOUND MULTIPLE EXAMPLES OF FAULTY PACKAGING IN BOTH 1" AND 1.5" LENGTH NEEDLES OF VARIOUS GAUGES. WE TOOK PICTURES OF SAMPLES AND HAVE RETAINED SOME OF THE FAULTY PACKAGES. WE ALSO NOTIFIED OUR DISTRIBUTER OF THE PROBLEM ON 7/24/2008. PLEASE NOTE THAT THIS WAS DISCOVERED DURING THE NORMAL COURSE OF BUSINESS, AND NOT AS A RESULT OF AN ADVERSE EVENT. SPECIFICALLY, WITH THE KINGLI PRODUCTS, THE FOLLOWING 5 NEEDLE BOXES CONTAINED FAULTY PACKAGING: 1" 32 GAUGE .25 X .25, DATED 6/27/2007 TO 6/27/2010; 1" 32 GAUGE .22 X .25, DATED 11/26/2007 TO 11/26/2010; 1" 32 GAUGE .20 X .25, DATED 9/25/07 TO 9/25/2010; 1.5" 30 GAUGE .30X 40 DATED 10/7/2005 TO 10/7/2008. 1.5" 30 GAUGE .25 X .40 DATED 10/5/2006 TO 10/5/2009. 1.5" 30 GAUGE .20 X .40 DATED 9/25/2007 TO 9/25/2010. SHOULD ADD'L INFO BE REQUIRED PLEASE CONTACT US.