CARDINAL

Description of Event or Problem

STAFF NOTED THAT THERE IS NO FILTER NEEDLE INCLUDED IN THIS KIT, ALTHOUGH THE MEDICATION INCLUDED IN THE KIT IS IN AN AMPULE. ALL LOTS FROM THIS PRODUCT ARE AFFECTED--THIS IS NOT A CASE OF A FILTER NEEDLE MISSING FROM ONE KIT: IT IS NOT INCLUDED IN THE KIT AT ALL. ALL CLINICAL REFERENCES INDICATE THAT A MEDICATION DRAWN FROM AN AMPULE SHOULD BE DRAWN UP WITH A FILTER NEEDLE. WHEN INTERVIEWING NURSING STAFF AND PHYSICIANS WHO USE THIS KIT ROUTINELY, ALL INDICATED THAT "EVERYTHING NEEDED IS IN THE KIT." IT IS NOT THEIR PRACTICE TO PULL A STERILE FILTER NEEDLE OR USE ONE WHEN USING THE KIT, ALTHOUGH ALL SAID THAT IF THEY WERE DRAWING UP FROM AN AMPULE, A FILTER NEEDLE SHOULD BE USED. MEMBERS OF THE HEALTHCARE TEAM RECOMMEND THE MANUFACTURER CONSIDER ONE OF THE FOLLOWING:1. CHANGE THE MEDICATION IN THE KIT FROM AN AMPULE TO A MULTI-DOSE VIAL.2. INCLUDE A FILTER NEEDLE IN THE KIT AS A STANDARD PIECE OF EQUIPMENT IF A MULTI-DOSE VIAL IS NOT AN OPTION.3. REFERENCE CURRENT LITERATURE AND/OR RESEARCH FINDINGS REGARDING DRAWING UP MEDICATIONS FROM AN AMPULE WITHOUT A FILTER NEEDLE. MANUFACTURER RESPONSE (AS PER REPORTER) FOR LUMBAR PUNCTURE TRAY, CARDINALA COPY OF THIS REPORT HAS BEEN FAXED TO THE MANUFACTURER.