Description of Event or Problem · 1
MCGAW, INC. 2525 MCGAW AVE, PO BOX 19791, IRVINE, CA 92712-9791. RECENTLY, MCGAW HAS EXPERIENCED AN INCREASE IN REPORTS OF SEPARATION OF THE TUBING AT THE FILTER CONNECTION. ON 1/19, A PRODUCT RECALL WAS SENT TO OUR CUSTOMERS (COPY ATTACHED). OUR INVESTIGATION HAS FOUND THE SEPARATION TO BE CAUSED BY AN INADEQUATE SOLVENT BOND BETWEEN THE TUBING AND THE 1.2 MICRON FILTER. THE SEPARATION MAY OCCUR DURING USE OF THE PRODUCT RESULTING IN LEAKAGE OF INTRAVENOUS FLUID AND/OR BLOOD LOSS, THUS ALLOWING FOR A POTENTIAL CONCERN. WE ARE CURRENTLY QUALIFYING AN IMPROVED SOLVENT MIXTURE. PRELIMINARY TESTING SHOWS THIS SOLVENT WILL ELIMINATE THE POTENTIAL FOR SEPARATION AT THIS JOINT. WE ANTICIPATE NEW PRODUCT WILL BE AVAILABLE WITHIN 45 DAYS. IN THE MEAN TIME, THE FOLLOWING MFR'S PRODUCTS COULD BE USED: ABBOTT CAT NUMBER 11415-48, B. BRAUN CAT NUMBER FE1209L, AND MEDEX CAT NUMBER MX448-FHB. WITH REGARDS TO THE RETURNED SAMPLE FOUND TO BE SEPARATED AT THE CHECK VALVE; OUR VISUAL INSPECTION FOUND THE CHECK VALVE TO EXHIBIT INSUFFICIENT SOLVENT APPLICATION. THE CHECK VALVE COMPONENTS ARE MACHINE ASSEMBLED WITH A 100% VISUAL INSPECTION PERFORMED PRIOR TO RELEASE. APPARENTLY, THIS UNIT WAS INADVERTENTLY MISSED DURING THAT INSPECTION. THE PRODUCTION WORKERS IN THE MFG AREA AND PRODUCT ENGINEERS HAVE BEEN INFORMED OF THIS COMPLAINT. ADDITIONALLY, THE ASSEMBLERS HAVE BEEN PROVIDED ADD'L TRAINING TO HELP ENSURE THAT THIS PROBLEM DOES NOT OCCUR IN THE FUTURE. MR LASELL, I WANT TO THANK YOU AGAIN FOR YOUR PATIENCE AND CONSIDERATION IN BRINGING THIS MATTER TO OUR ATTENTION. PLEASE ACCEPT OUR APOLOGIES FOR ANY INCONVENIENCE CAUSED DURING THIS TIME OF PRODUCT IMPROVEMENT. SHOULD ADD'L QUESTIONS OR CONCERNS ARISE, DO NOT HESITATE TO CONTACT ME.