Description of Event or Problem · 1
ATTEMPTED IPICC INSERTION LEFT ARM, UPPER CEPHALIC VEIN. UNEVENTFUL INSERTION, CATH ADVANCED EASILY, GOOD BLOOD RETURN. BREAKAWAY NEEDLE WAS DIFFICULT TO SEPARATE. FINALLY BROKE INTO TWO HALVES AS DESIGNED AND REMOVED FROM CATH. CATH WAS ADVANCED FULLY INTO THE VEIN AS FAR AS THE WINGS AND FLUSHED WITH SALINE. FLUSHED WITH HEPARIN SOLUTION AND NOTED FLUID LEAKING BACK FROM SITE AND BULGING ABOVE SITE. CATHETER CAME OUT ENTIRELY, HAVING BEEN SEVERED APPROXIMATELY 1/2" ABOVE WINGS. APPROXIMATELY 14" OF CATHETER TUBING WAS RETAINED IN PATIENT'S ARM. TUBING REMOVED BY SURGICAL INTERVENTION - CUTDOWN.DEVICE 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, TELEMETRY FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. THE DEVICE WAS DESTROYED/DISPOSED OF.