D
Patient 1
DURING MANUAL VISUAL INSPECTION OF THE CULLED REJECTS FROM AUTOMATED (EISAI) INSPECTION OF THE FILLED SYRINGES FOR PRODUCT: HEPARIN LOCK FLUSH, LOT #H118248N ON (B)(6) 2018, THIRTEEN SYRINGES WERE DISCOVERED TO HAVE PIN HOLES IN THE YELLOW TIP CAPS. INVENTORY AND BATCH RECORDS WERE REVIEWED TO IDENTIFY POTENTIALLY DEFECTIVE YELLOW TIP CAP LOTS AND THE FINISHED PRODUCT BATCHES WHERE THESE YELLOW TIP CAP LOTS WERE USED. IT WAS DISCOVERED THAT THE FOLLOWING LOTS RELEASED TO THE MARKET USING SAME LOTS OF TIP CAP USED IN LOT #H118248N. BATCH NUMBER: H118165N - HEPARIN I.V. FLUSH SYRINGE; 500 UNITS/5 ML; 5 ML FILL IN 12 ML SYRINGE, CATALOG NUMBER: MIH-3335; H118174N - HEPARIN I.V. FLUSH SYRINGE; 500 UNITS/5 ML; 5 ML FILL IN 12 ML SYRINGE, MIH-3335; H118183N - HEPARIN I.V. FLUSH SYRINGE; 500 UNITS/5 ML; 5 ML FILL IN 12 ML SYRINGE, MIH-3335; H118190N - HEPARIN I.V. FLUSH SYRINGE; 300 UNITS/3 ML; 3 ML FILL IN 6 ML SYRINGE, MIH-3323; H118191N - HEPARIN I.V. FLUSH SYRINGE; 500 UNITS/5 ML; 5 ML FILL IN 12 ML SYRINGE, MIH-3335; H118200N - HEPARIN I.V. FLUSH SYRINGE; 500 UNITS/5 ML; 5 ML FILL IN 12 ML SYRINGE, MIH-3335; H118206N - HEPARIN I.V. FLUSH SYRINGE; 300 UNITS/3 ML; 3 ML FILL IN 12 ML SYRINGE, MIH-3335; H118216N - HEPARIN I.V. FLUSH SYRINGE; 300 UNITS/3 ML; 3 ML FILL IN 12 ML SYRINGE, MIH-3333; H118220N - HEPARIN I.V. FLUSH SYRINGE; 500 UNITS/5 ML; 5 ML FILL IN 12 ML SYRINGE, MIH-3335. MEDEFIL, INC HAS INITIATED AN INVESTIGATION FOR THE ABOVE MENTIONED FINISHED PRODUCT LOTS THAT ARE SHIPPED FROM OUR WAREHOUSE AND THE INVESTIGATION IS STILL UNDERWAY.