RATE-FLOW

Additional Manufacturer Narrative

INVESTIGATION THE REVIEW OF OUR INTERNAL NONCONFORMANCE AND COMPLAINTS SYSTEM DID NOT IDENTIFY ANY QUALITY ISSUES OR TRENDS IN THE BATCH RECORD OF THE AFFECTED PRODUCT. THE UNIT (1) RELATED TO THIS COMPLAINTWAS RECEIVED AND SENT TO OUR QUALITY DEPARTMENT FOR ASSESSMENT. SMALL SCRATCHES WERE FOUND NEAR THE DISTAL END CONNECTOR THAT CAUSE A HOLE IN THE TUBE. RETAINED UNITS OF THE SAME LOT NUMBER AS THE ONE INFORMED WERE SENT TO VISUAL INSPECTION AND LEAK TEST AND NO DEFECT WAS FOUND. CONCLUSION ACCORDING TO THE INVESTIGATION PERFORMED, THE EVENT WAS CONFIRMED AND THE ROOT CAUSE FOUND. THE MARKS DETECTED CAN BE CONSIDERED AS A NORMAL RESULT OF THE AUTOMATED MANUFACURING PROCES THAT DO NOT AFFECT THE PRODUCT FUNCTIONALITY. HOWEVER, A MISALIGNEMENT OF THIS MACHINE COULD PRODUCE DEEPER SCRATCHES THAT COULD FINALLY LEAD TO A LEAK. THE INFORMED EVENTCOULD BE CONSIDERED WITHIN OUR ACCEPTANCE QUALITY LEVEL (AQL) AND WILL BE MONITORED FOR STATISTICAL ANALYSIS AND PERIODIC TRENDING IN ORDER TO DETECT ANY TENDENCY THAT MAY NEED AN ACTION FROM OUR SIDE.

Description of Event or Problem

MEDWATCH REPORT IDENTIFIED IN MAUDE DATABASE STATES: AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLOOD BACK FLOW, LEAKING.DETAILED INQUIRY DESCRIPTION: FROM CUSTOMER: IV TUBING USED WASTHE BRAUN 0.2 LINE LOT 0061829317 AND BRAUN FLOW REGULATOR SET LOT 221501L.PATIENT WAS CONNECTED TO IV LINE POST IV INSERTION, BLOOD FLOWED BACKUP THE TUBING (TOURNIQUET WAS OFF), AND THEN CONTINUED TO LEAK OUT OF TUBING.PATIENT WAS DISCONNECTED AND I CONNECTED THEM TO A SALINE LOCKWHICH I LUCKILY HAD RIGHT BESIDE ME.PATIENT DID GO VASOVAGAL WITH LIGHT HEADINESS, AND LOOKED SLIGHTLY PALE.I BELIEVE THE LEAK WAS WITH THE IVTUBING AND NOT FLOW REGULATOR BUT I COULD NOT EXACTLY PINPOINT AT WHAT SITE.MY FIRST THOUGHT WHEN I NOTICED THE BLOOD FLOW RETURN WAS THE CONNECTIONWAS LOOSE BUT WHEN I TIGHTENED IT CONTINUED TO FLOW UPWARDS THEN STARTED LEAKING.