STERICYCLE BIO SYSTEMS
Received May 5, 2015 · Event occurred Apr 15, 2015
Report 4886754 · MDR key 4886754
Device
Generic name
Container, Sharps
Manufacturer
Stericycle, Inc.Model number
C-03RES-0203-OCCatalog number
*
Lot number
*
Product problems
- Device Inoperable
- Temperature Problem
Patient
*
- Needle Stick/Puncture
Narrative
Description of Event or Problem
IN 2015, AN ENVIRONMENTAL SERVICES EMPLOYEE AT THE HOSPITAL SUSTAINED A NEEDLE STICK IN THE PROCESS OF REMOVING A FULL (AND PRESUMABLY SECURELY LOCKED) SHARPS CONTAINER INSERT, IN ORDER TO REPLACE IT WITH AN EMPTY SHARPS INSERT. AS HE LIFTED THE CONTAINER FROM THE HOLDER (WHICH WAS MOUNTED ON A WALL), A NUMBER OF SHARPS SPILLED OUT AND HE SUSTAINED A NEEDLE STICK TO HIS LEFT THUMB. HE WAS SEEN BY A HEALTHCARE WORKER FOR HIS INJURY AND PLACED ON A 28 DAY COURSE OF PROPHYLACTIC MEDICATIONS. IN ADDITION TO THE NON-FUNCTIONING LOCK, THE SHARPS CONTAINER WAS NOTED TO BE FILLED BEYOND THE FILL LINE - WHICH LIKELY CONTRIBUTED TO THE NUMBER OF SHARPS THAT SPILLED OUT OF THE BOX WHEN IT WAS LIFTED FROM THE HOLDER. THE LIKELY REASON THAT THE CONTAINER HAD BEEN OVERLY FILLED IS THAT THE INSERT IS RED AND IT IS DIFFICULT TO SEE WHETHER SHARPS HAVE REACHED ABOVE THE FILL LINE. IN ADDITION, THE CONTAINER HAD BEEN MOUNTED SEVERAL INCHES HIGHER THAN RECOMMENDED. THIS HAS BEEN CORRECTED.THE CONTAINER WAS RETURNED TO THE COMPANY VIA THE REP BEFORE THE INCIDENT WAS REPORTED TO RISK MANAGEMENT. ACCORDING TO THE HOSPITAL EMPLOYEE WHO RETURNED THE CONTAINER TO THE COMPANY'S REPRESENTATIVE, THE REP INDICATED THAT THE COMPANY BELIEVED THE PROBLEM OF THE LOCKS NOT ALWAYS FUNCTIONING PROPERLY WAS RELATED TO CHANGES IN TEMPERATURE THAT CAUSES THE MATERIAL TO EXPAND OR CONTRACT, AND THAT OVER TIME THIS MAY RESULT IN LOOSENING OF THE LOCK. THE REP ADVISED THAT WHEN THE SHARPS INSERT CONTAINERS ARE BEING REMOVED, THEY SHOULD NOT BE GRABBED BY THE LID. WHEN THE STERICYCLE ACCOUNT MANAGER SUBSEQUENTLY CAME TO THE HOSPITAL AND ASKED TO SEE THE CONTAINER WITH THE MALFUNCTIONING LOCK, ENVIRONMENTAL SERVICES INFORMED HER THAT THE REP HAD ALREADY PICKED THIS UP. THE HOSPITAL ENVIRONMENTAL SERVICES EMPLOYEE THEN ASKED ABOUT THE VARIOUS COLORS OF THE SHARPS CONTAINERS, AS THE MOST OPAQUE OF THE RED CONTAINERS MAKES IT DIFFICULT TO DETERMINE IF A CONTAINER IS OVER-FILLED. THE ACCOUNT MANAGER SAID THAT THE CONTAINERS ARE RED WHEN NEW AND FADE AFTER MULTIPLE WASHINGS. WHEN A CONTAINER HAS BEEN WASHED 600 TIMES IT IS NO LONGER USED. ANY CONTAINER THAT IS CLEAR SHOULD NO LONGER BE USED.