DBC SPRINGTEN 0.25X30
Received Oct 30, 2008 · Event occurred Sep 25, 2008
Report MW5008835 · MDR key 1217529
Device
Generic name
Acupunture Needles
Product problems
- Device Expiration Issue
- Tear, Rip or Hole in Device Packaging
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AS FOLLOW UP TO FILED IN 2008, NEW ACUPUNCTURE NEEDLES FROM DIFFERENT MFR WERE ORDERED TO REPLACE THE PREVIOUSLY REPORTED FAULTY PACKAGES. ON THE FOLLOWING MONTH, WE DISCOVERED A SIMILAR PROBLEM WITH FIVE PACKAGES OF DBC SPRINGTEN 0.25X30, EXPIRATION DATE 2011-06 SINGE USE ACUPUNCTURE NEEDLES. THESE ARE PACKAGES THAT CONTAIN MULTIPLE (10) LOOSE NEEDLES PLUS A GUIDE TUBE IN STERILE PACKAGING. IT APPEARS THAT THROUGH SHIPPING AND HANDLING, IN SOME INSTANCES, THE TIPS OF THE NEEDLES HAVE PENETRATED THE PLASTIC SHEATH AND PROTRUDE FROM THE PACKAGE COMPROMISING BOTH STERILITY AND CREATING A NEEDLE STICK HAZARD. WE TOOK DIGITAL PICTURES OF THE PACKAGING, CONTACTED OUR SUPPLIER AND PROVIDED THEM WITH COPIES OF THE PHOTOS. BOTH THIS SUPPLIER AND THE PREVIOUS SUPPLIER HAVE INDICATED CORRESPONDENCE WITH THE MFR'S AND THAT STEPS WERE BEING TAKEN TO CORRECT THE PACKAGING. WE HAVE REQUESTED WRITTEN DOCUMENTATION, BUT HAVE NOT YET RECEIVED ANY. PLEASE NOTE THAT THIS WAS DISCOVERED DURING THE NORMAL COURSE OF BUSINESS AND WAS NOT AS A RESULT OF AN ADVERSE EVENT.