INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REGARDING 5CC AND 3CC SYRINGES IN FINISHED GOOD (B)(4) (PAIN TRAY). WHEN FILLED, SMALL BLACK FOREIGN OBJECTS COULD BE SEEN FLOATING IN THE SYRINGES, WHICH WERE INTENDED TO BE USED FOR INJECTION. A SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED MAY 9. AN EVALUATION OF THE SAMPLE CONFIRMED THE REPORTED ISSUE. (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
D
Patient 1
THE 5CC AND 3CC SYRINGES IN THE PACK ARE FILLED WITH MEDICATION FOR INJECTION, AND ON MULTIPLE OCCASIONS, THERE HAVE BEEN VERY SMALL BLACK FOREIGN OBJECTS FLOATING IN THE SYRINGES. THE DOCTOR WAS UNABLE TO USE THE SYRINGE WHEN THIS HAPPENS, AND A NEW ONE IS PULLED TO COMPLETE THE PROCEDURE.
N
Patient 1
ROOT CAUSE: THE SYRINGES WITHIN THE CONVENIENCE KIT ARE SUPPLIED TO DEROYAL BY (B)(4) INC. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN ITS RESPONSE, (B)(4) STATED THE MALE MOLD COMPRESSES THE VULCANIZED RUBBER SHEET INTO THE FEMALE MOLD TO FORM THE PISTON TIP. ANOTHER MACHINE THEN PUNCHES EACH PISTON TIP OUT OF THE SHEET. DURING THIS PUNCH PROCESS, LOOSE RUBBER PARTICLES CAN BE CREATED. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, THE SUPPLIER STATED THE PLUNGER MANUFACTURER HAS A MECHANICAL SHAKING PROCESS TO DISLODGE ANY PARTICULATE PRESENT AND THEN WATER WASH STEPS TO REMOVE THESE PARTICULATES. THERE IS ALSO ADDITIONAL INCOMING IN-PROCESS INSPECTION AND FINAL INSPECTION PROCESSES TO CONTROL THE ISSUE. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REGARDING 5CC AND 3CC SYRINGES IN FINISHED GOOD (B)(4) (PAIN TRAY). WHEN FILLED, SMALL BLACK FOREIGN OBJECTS COULD BE SEEN FLOATING IN THE SYRINGES, WHICH WERE INTENDED TO BE USED FOR INJECTION. A SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED MAY 9. AN EVALUATION OF THE SAMPLE CONFIRMED THE REPORTED ISSUE. THE SYRINGES (RAW MATERIALS (B)(4)) ARE SUPPLIED TO DEROYAL BY (B)(4). A SCAR WAS ISSUED TO (B)(4) AND A RESPONSE HAS BEEN RECEIVED. IN ITS RESPONSE, THE SUPPLIER INDICATED INVENTORY WAS STATISTICALLY SAMPLED AND NO ISSUES WERE FOUND. THE VISUAL INSPECTION SAMPLING PROCESS HAS BEEN INCREASED FOR THE REQUESTED ISSUE. THE WORK ORDER FOR THE FINISHED GOOD WAS REVIEWED FOR DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. DEROYAL WILL CONTINUE TO MONITOR POST MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE REOCCURS AFTER THE IMPLEMENTED ACTIONS. PREVENTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
D
Patient 1
THE 5CC AND 3CC SYRINGES IN THE PACK ARE FILLED WITH MEDICATION FOR INJECTION, AND ON MULTIPLE OCCASIONS, THERE HAVE BEEN VERY SMALL BLACK FOREIGN OBJECTS FLOATING IN THE SYRINGES. THE DOCTOR WAS UNABLE TO USE THE SYRINGE WHEN THIS HAPPENS, AND A NEW ONE IS PULLED TO COMPLETE THE PROCEDURE.