Description of Event or Problem · 1
A NEWBORN WAS LYING IN CRIB ON ABDOMEN; HEAD TO SIDE WITH PACIFIER IN MOUTH. INFANT PUT LEFT RING FINGER THROUGH ONE OF THE HOLES IN THE WHITE PLASTIC SHEILD OF THE PACIFIER. WHEN DISCOVERED THE FINGER WAS SWOLLEN & NURSES HAD TO USE LOTION TO GET FINGER OUTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.