Description of Event or Problem · 0
BD 10FR ROUND DRAINS. WE OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER 072221. ALL (3 PACKAGES) HAD SAME LOT NUMBER: NGKP0821 SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW. 1. WE ARE FINDING DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. 2. VERY OFTEN THE DRAINS HAVE SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT IS SO FREQUENT THAT SURGEON HAS THE STAFF CHECK THE TUBING BEFORE WE INSERT THEM. ACCORDING TO SOME, THEY SEE THIS ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN THE MANUFACTURING CHANGED. 3. THERE HAVE BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR JELL THAT IS AT THE END OF THE DRAIN BY THE TROCAR WAS FILLING THE FLUTED PART OF THE DRAIN AS WELL SO IT WAS NOT ABLE TO HOLD SUCTION. SURGEON IS HAVING STAFF FLUSH ALL THE DRAINS NOW BEFORE PLACEMENT AND CLOSE THE INCISION, SO WE KNOW THEY FUNCTION. EMI HAS FOUR DRAINS THAT SHE IS SENDING TO PRODUCT DEFECT TODAY [DATE REDACTED]. BD 10FR ROUND DRAINS REF. 072221 NGJW3604. PATIENT HERE FOR SURGERY. SURGEON ALWAYS USES TWO 10FR ROUND DRAINS. OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. BD 10FR ROUND DRAINS. REF 072221. NGKP0821. BL OPERATING ROOM DRAIN ISSUES - SURGICAL DRAIN BULBS HAD DEBRIS IN THEM. THESE RANGED FROM HAIR TO BLACK SPECS AND OTHER UNIDENTIFIABLE OBJECTS. THE LOTS INCLUDE: NGHZ0309, NGKQ2776, NGJW3939, AND NGKQ0974. PRODUCT INFORMATION AS FOLLOWS: CARDINAL HEALTH JACKSON-PRATT 400ML RESERVOIR, REF: SU130-1000, AND BD DAVOL 100CC SILICONE CLOSED WOUND SUCTION EVACUATOR, REF: 0070740.