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, WHILE MAKING THE NORMAL ROUNDS ON PATIENT, THE NURSE FOUND THAT THE CATHETER EXTENSION SET HAD COME APART AT THE CONNECTIN TO THE HEP LOCK CAP. THE NURSE ESTIMATED THAT THE PATIENT HAD LOST AROUND 300-400 ML OF BLOOD. THE I.V. WAS RESTARTED.

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 PROVIDER TO OBTAIN ADDITIONAL INFORMATION AND THE MANUFACTURER IS STILL ATTEMPTING TO ACQUIRE THE DEVICE FOR TESTING. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE DEVICE IS RETURNED FOR TESTING. THE LOT NUMBER/DATE OF MANUFACTURE WAS NOT KNOWN BECAUSE THE DEVICE PACKAGING HAD BEEN DISCARDED PRIOR TO THE DEVICE ISSUE.