MANOMETER TRAY STERILE 10/BX - 4330

Additional Manufacturer Narrative

(B)(4) INITIAL EMDR SUBMISSION. (B)(4). NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. SHOULD YOU EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT, EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

Description of Event or Problem

IT WAS REPORTED MANOMETERS THAT ARE USED ARE LEAKING WHEN CONNECTED TO THE STOPCOCK. EMAIL VERBATIM: "GOOD AFTERNOON, THE MANOMETERS THAT ARE USED IN THE DEPARTMENT OF NEURORADIOLOGY, LOT# 000141691, ARE LEAKING WHEN CONNECTED TO THE STOPCOCK. THIS MAY CAUSE AN INCORRECT READING WHEN MEASURING PRESSURES. REFERENCE # (B)(4). DESCRIPTION IS "MANOMETER, 550 ML, THREE  WAY STOPCOCK. COMPANY IS CAREFUSION. HOSPITAL STOREROOM BIN # IS (B)(4). WE DO HAVE ANOTHER LOT THAT DOES NOT LEAK, # (B)(4). BUT WE ONLY HAVE 2. I WILL NEED MORE SHORTLY, BUT NOT SURE WHAT LOT WILL COME UP FROM STOREROOM. I AM THANKFUL FOR ANY GUIDANCE YOU CAN GIVE ME. THANK YOU".