UNKNOWN

Description of Event or Problem

SHEATH PULLED AS ORDERED BY PHYSICIAN AT 1400. WHEN SHEATH WAS PULLED, HUB OF SHEATH CAME APART FROM THE REST OF THE SHEATH. THE REMAINING CATHETER WAS LEFT STICKING APPROXIMATELY 1/3" OUT OF INSERTION SITE. CATHETER RETREIVED WITH MUCH DIFFICULTY BY GRASPING. PATIENT EXPERIENCE MORE BLOOD LOSS THAN NORMAL WHEN PULLING SHEATHSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.