Description of Event or Problem · 1
INFO REPORT: THIS DEVICE CASE, WHICH DID NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A PHYSICIAN VIA A SALES REP, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT. THE PT'S MEDICAL HISTORY, CONCURRENT CONDITION, AND CONCOMITANT DRUG INFO WAS NOT PROVIDED. THE PT WAS RECEIVING AN UNSPECIFIED TYPE AND BRAND OF INSULIN VIA A HUMAPEN ERGO BURGENDY OPAQUE PEN BODY (LOT: A1461) WITH A CLEAR CARTRIDGE HOLDER (LOT: CC) ATTACHED BEGINNING ON AN UNKNOWN DATE. THE OPERATOR OF THE THE DEVICE WAS NOT PROVIDED AND IT IS NOT KNOWN IF THE OPERATOR WAS A TRAINED USER. ON AN UNKNOWN DATE, THE PT COMPLAINED TO THE REPORTING PHYSICIAN THAT THE INSULIN DID NOT COME OUT FROM THE PEN, AND IT WAS FOUND THAT BOTH ENGAGEMENT TABS OF THE CARTRIDGE HOLDER WERE BROKEN. THE PEN WAS DISCONTINUED ON 8/16/2002. THE HUMAPEN ERGO DEVICE (PEN BODY LOT: A1461, CLEAR CARTRIDGE HOLDER LOT: CC) WAS RETURNED TO THE COMPANY FOR ANALYSIS. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPARTMENT ON 8/20/2002 CONFIRMED THAT THE CLEAR CARTRIDGE HOLDER HAD BROKEN ENGAGEMENT TABS. DETAILED ANALYSIS ON 8/27/2002 AND WITH CONCLUSION SUMMARY ON 9/5/2002: INVESTIGATION REVEALED DAMAGE CONSISTENT WITH DAMAGE THAT OCCURRED WHILE IN THE FIELD BY BENDING OF THE TABS BACK AND FORTH UNTIL FRACTURE. BOTH ENGAGEMENT TABS WERE REMOVED AT THE BASE.