D
Patient 1
RUBBER CAPS OF BLOOD CAPILLARY TUBES CAME LOOSE ALLOWING BLOOD SAMPLES TO LEAK OUT OF THE TUBES. IT WAS NECESSARY TO EITHER STICK THE PATIENT A SECOND OR THIRD TIME OR SOMETIMES HAND CARRY THE SAMPLE TO THE BLOOD GAS LAB TO KEEP IT FROM LEAKING. THE PROBLEM OCCURRED SEVERAL TIMES DURING A PERIOD OF 3 MONTHS. THE MANUFACTURER WAS CONTACTED AND IDENTIFIED SOME CAP LOT NUMBERS WHICH WERE KNOWN TO HAVE A TENDENCY TO LEAK. SOME OF THE CAPS AT OUR HOSPITAL WERE WITHIN THOSE LOT NUMBERS. USERS DISTRIBUTE CAPS TO VARIOUS WORK LOCATIONS IN UNMARKED CONTAINERS. THE OLDEST LABELED LOT NUMBER FOUND WAS 0918023, BUT SOME STOCK COULD BE EVEN OLDER. ALL CAPS OF THE APPLICABLE LOTS, OLDER LOTS, AND ALL STOCK OF UNLABELED CAPS WERE REPLACED WITH THE NEW CAPS THE MANUFACTURER SUPPLIED. SINCE THE REPLACEMENT LEAKS HAVE NOT BEEN REPORTED. A COMPLICATING FACTOR IN THIS ISSUE WAS THE PRESENCE OF MIXED MANUFACTURERS OF CAPS AND TUBES IN USERS' SUPPLIES. AS A RESULT OF PREVIOUS ATTEMPTS TO RESOLVE THE LEAK PROBLEM, A QUANTITY OF INSTRUMENTATION LABS TUBES AND CAPS WERE OBTAINED, AND THOSE BECAME MIXED WITH THE RADIOMETER SUPPLIES. WHEN OUR TUBE CAPS WERE REPLACED, ALL NON-RADIOMETER STOCK WERE REMOVED AND DISCARDED.======================MANUFACTURER RESPONSE FOR CAPILLARY CAP, SAFECLINITUBES (PER SITE REPORTER).======================MANUFACTURER CONFIRMED THAT CAPS HAD BEEN REDESIGNED BEGINNING WITH LOT NUMBER 1037508. LOT NUMBER IS FOR THE BAGS OF CAPS ONLY. THE COMPLETE CAPILLARY TUBES BOX KIT BEARS A DIFFERENT CATALOG NUMBER AND AN UNRELATED LOT NUMBER. MANUFACTURER SUPPLIED CAPS TO REPLACE ALL OLD STOCK IN THE HOSPITAL. MANUFACTURER DID NOT REQUEST RETURN OF OLD STOCK. OLD CAPS WILL BE STORED FOR AT LEAST 30 DAYS BEFORE DISCARDING.