Description of Event or Problem · 1
THE PT RECEIVED SUBCUTANEOUS HUMAN INSULIN ISOPHANE SUSPENSION 70%/HUMAN REGULAR INSULIN 30% (HUMACART 3/7) VIA A HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT# A1502) FOR TYPE II DIABETES MELLITUS BEGINNING ON AN UNK DATE (DOSAGE NOT PROVIDED). FOLLOWING THE USE OF THE PEN, PT FOUND SOMETHING WRONG WITH OPERATION OF THE PISTON, AND VISITED THE HOSPITAL WITH THE PEN IN 2003. THE PEN WAS REPLACED TO A NEW ONE. NO ADVERSE EVENTS WERE EXPERIENCED. THE PT, TRAINING STATUS UNK, OPERATED THE PEN AND STORED IT AT ROOM TEMPERATURE. THIS PEN WAS USED AROUND 2001. THE EXPIRATION DATE WAS NOT PROVIDED. THE DEVICE WAS RETURNED TO THE AFILIATE QC IN 2003. INITIAL ANALYSIS BY THE AFILIATE QUALITY CONTROL DEPT FOUND: IT WAS CONFIRMED THAT THE INJECTION FORCE WAS A LITTLE HEAVY, BUT IT WAS NORMAL WITHIN LIMITS. THE PDS INVESTIGATION OF THE RETURNED DEVICE FOUND: SOFT TOUCH SEPARATION (BOND TISSUE), CAP CRACKED (RETENTION RING), TWO BROKEN CCH ENGAGEMENT TABS, AND TWO CRACKED CCH SPRING ARMS. NO CASE WAS RETURNED WITH THIS DEVICE . AN RFI WILL BE ISSUED FOR BROKEN CCH ENGAGEMENT TABS. BECAUSE THERE ARE TWO BROKEN ENGAGEMENT TABS, THIS COMPLAINT MUST BE CONSIDERED A CIRM. UPON INITIAL INSPECTION BY THE AFFILIATE NO BROKEN TABS WERE IDENTIFIED, HOWEVER IN NOVEMBER 2003, THE MFR IDENTIFIED TWO BROKEN ENGAGEMENT TABS WHICH ARE CONSIDERED A CIRM. CIRM WAS REPORTED BY THE MFR TO AFFILIATE IN MARCH 2004.