BLOOD RECIPIENT SET

Additional Manufacturer Narrative

E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. E1: INITIAL REPORTER PHONE NO: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED AN ADMINISTRATION SET FOR BLOOD AND BLOOD COMPONENTS LEAKED. AFTER THE NURSE PRIMED THE SET FROM THE TRANSFUSION BLOOD, THE NURSE REMOVED THE CAP TO CONNECT TO THE PATIENT AND THE BLOOD FLOWED OUT OF THE GIVING SET WITH THE ROLLER CLAMP CLOSED. THIS OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.