Description of Event or Problem · 1
THE PROBLEM IS DESCRIBED AS A DIFFICULTY IN SELF INJECTING THE 1CC SYRINGE BY 14 DIFFERENT PTS, CLAIMING THE PLUNGER WAS VERY DIFFICULT TO PUSH. 14 SAMPLES WERE SENT TO MFR FOR EVAL. MFR CLAIMS ONLY TWO OF THE SYRINGES HAD A CONFIRMED CONDITION OF A CLOGGED NEEDLE AND A BROKEN PLUNGER. AFTER REPEATED CALLS BACK TO MFR QA DEPT TO EXPLAIN THAT FACILITY DID IN FACT HAVE A LIST OF 14 DIFFERENT PTS WITH SIMILAR COMPLAINTS AND THAT RPTR NEEDED THE SUPPLIER TO BUY MORE PRODUCT FOR RPTR IN A DIFFERENT LOT NUMBER, CO WAS QUICK TO TELL RPTR THAT LOT NUMBER SALES COULD NOT BE GUARANTEED, AND THAT CO WOULD NOT PICK UP THE SYRINGES. RPTR HAS ALSO BEEN IN TOUCH WITH FIELD REP FOR B/D, AND RPTR FEELS REP IS DOING ALL SHE CAN TO HELP. AS OF 4/27/98, NOTHING POSITIVE HAS BEEN ACCOMPLISHED. FACILITY'S PHARMACY MGR HAS INDICATED SHE FEELS A PRODUCT FAILURE HAS OCCURRED. THE LOT NUMBER HAS BEEN ISOLATED AND FACILITY WILL CONTINUE TO PRESS B/D TO CORRECT THE MATTER. SO FAR, IT APPEARS NO ATTEMPT HAS BEEN MADE TO CORRECT IT. A CALL WAS PLACED TO THE MGR OF THE QA DEPT, BUT WAS NOT RETURNED. MFR WRITES: "THANK YOU FOR CONTACTING BECTON DICKINSON REGARDING OUR ALLERGY SYRINGE. WE UNDERSTAND YOU REPORTED HAVING DIFFICULTIES WITH THE PLUNGER MOVEMENT WHEN USING THE SYRINGES. DIV QUALITY/REGULATORY SYS HAS EVALUATED YOUR REPORT AND SAMPLES. CONDITION HAS BEEN CONFIRMED ON TWO (2) OUT OF THE FOURTEEN (14) SAMPLES SUBMITTED. THE CONDITION REPORTED ON THOSE TWO SAMPLES WAS DUE TO A CLOGGED NEEDLE AND TO A BROKEN PLUNGER ROD, WHICH IN BOTH INSTANCES, AFFECTED THE PUNGER MOVEMENT. THE REST OF THE SYRINGES DID NOT SHOW ANY DEFECTS. WE ARE UNABLE TO DETERMINE THE ORIGIN OF THESE CONDITION. THE MFG FACILITY WILL RECEIVE A COPY OF THIS REPORT FOR THEIR RECORDS. WE REGRET ANY INCONVENIENCE THAT MAY HAVE RESULTED FROM THIS INCIDENT. SHOULD YOU HAVE ANY QUESTIONS REGARDING THIS INCIDENT, PLEASE CONTACT BECTON DICKINSON DIV QUALITY/REGULATORY SYS AT 1-800-333-4813.