Description of Event or Problem · 1
RESIDENT ADMITTED TO NURSING FACILITY WITH MALE EXTERNAL CONDOM CATHETER IN TACT AND CONNECTED TO STRAIGHT DRAINAGE. THE FOLLOWING ARE RESIDENT OBSERVED WITH EDEMATOUS, DISCOLORED PENIS. A CONDOM CATHETER WAS TIGHTLY WRAPPED BY UNKNOWN PERSON, CONSTRICTING BLOOD FLOW TO PENIS. THE CONDOM CATHETER WAS IMMEDIATELY REMOVED AND THE PHYSICIAN NOTIFIED. RESIDENT TRANSFERRED TO HOSPITAL VIA AMBULANCE WHERE A PARTIAL AMPUTATION OF THE PENIS WAS PERFORMED. EMPLOYEES HAVING CONTACT WITH THE RESIDENT WERE QUESTIONED AND THE FACILITY INQUIRIES COULD FIND NO EVIDENCE OF THE STAFF HAVING CHANGED THE CONDOM CATHETER OR HOW THE DEVICE WRAPPER BECAME STRETCHEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, INCORRECT TECHNIQUE/PROCEDURE, MISAPPLICATION OF DEVICE, INHERENT RISK OF PROCEDURE, KNOWN SHORT TERM COMPLICATION OF PROCEDURE, PATIENT'S CONDITION - PREDISPOSED EVENT, PATIENT DIAGNOSIS CONTRAINDICATED USE OF DEVICE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.