RATE FLOW®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLOOD BACK FLOW, LEAKING. DETAILED INQUIRY DESCRIPTION: FROM CUSTOMER: IV TUBING USED WAS THE BRAUN 0.2 LINE LOT 0061829317 AND BRAUN FLOW REGULATOR SET LOT 221501L. PATIENT WAS CONNECTED TO IV LINE POST IV INSERTION, BLOOD FLOWED BACK UP THE TUBING (TOURNIQUET WAS OFF), AND THEN CONTINUED TO LEAK OUT OF TUBING. PATIENT WAS DISCONNECTED AND I CONNECTED THEM TO A SALINE LOCK WHICH I LUCKILY HAD RIGHT BESIDE ME. PATIENT DID GO VASOVAGAL WITH LIGHT HEADINESS, AND LOOKED SLIGHTLY PALE. I BELIEVE THE LEAK WAS WITH THE IV TUBING 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 CONNECTION WAS LOOSE BUT WHEN I TIGHTENED IT CONTINUED TO FLOW UPWARDS THEN STARTED LEAKING.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4).THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THROUGH VISUAL EXAMINATION OF THE RECEIVED SAMPLE, IT WAS OBSERVED THAT SMALL SCRATCHES WERE FOUND NEAR THE DISTAL END CONNECTOR THAT CAUSED A HOLE IN THE TUBE. RETAINED SAMPLES OF THE SAME LOT NUMBER WERE EXAMINED AND LEAK TESTED; NO DEFECTS WERE FOUND ON THE RETAINED SAMPLES. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. THE MARKS DETECTED (SMALL SCRATCHES) CAN BE CONSIDERED A NORMAL RESULT OF THE AUTOMATED MANUFACTURING PROCESS THAT DO NOT AFFECT THE PRODUCT FUNCTIONALITY. HOWEVER, A MISALIGNMENT OF THIS MACHINE COULD PRODUCE DEEPER SCRATCHES THAT COULD LEAD TO A HOLE/LEAK. BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT THIS WAS AN ISOLATED INCIDENT. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.