HENORA 300PSI I.V. CATHETER EXTENSION SET

Description of Event or Problem

THE CATHETER EXTENSION SET HAD BEEN PREVIOUSLY PUT IN PLACE ON THE PATIENT BY EMERGENCY ROOM STAFF AT AN EARLIER TIME. DURING THE NIGHT, THE PATIENT RANG THEIR CALL BELL BECAUSE THEY FELT PART OF THE BED GETTING WET BY WHERE THE IV SET WAS PLACED. THE NURSE ANSWERED THE CALL AND FOUND THAT CATHETER EXTENSION SET HAD COME APART AT THE CONNECTION TO THE HEP LOCK CAP. THE NURSE ESTIMATED THAT THE PATIENT HAD LOST AROUND 250 ML OF BLOOD. THE PATIENT WAS NOT INJURED AND THE I.V. WAS RESTARTED WITHOUT INCIDENT.

Additional Manufacturer Narrative

THERE HAVE BEEN DIFFICULTIES COMMUNICATING WITH THE HEALTH CARE PROVIDER ABOUT THE RETURN OF THE DEVICE. NUMEROUS ATTEMPTS HAVE BEEN MADE BY TELEPHONE AND E-MAIL TO CONTACT THE HEALTH CARE PROVIDED TO OBTAIN ADD'L INFO AND THE MANUFACTURER IS STILL ATTEMPTING TO ACQUIRE THE DEVICE FOR TESTING. THE LOT NUMBER/DATE OF MANUFACTURE WAS NOT KNOWN BECAUSE THE DEVICE PACKAGING HAD BEEN DISCARDED PRIOR TO THE DEVICE ISSUE.