TEMNO NEEDLE BIOPSY 18GX15CM ADJ COAXIAL

Additional Manufacturer Narrative

(B)(4). ONE (1) SAMPLE FROM LOT #0001022711 WAS PROVIDED FOR EVALUATION. DURING VISUAL ANALYSIS IT WAS IDENTIFIED THERE WAS A CLEAR DOT OF WHAT APPEARED TO BE ADHESIVE WITHIN A COUPLE INCHES OF ONE SIDE OF THE TIP OF THE CANNULA. THE ADHESIVE DOT WAS LARGE ENOUGH TO PREVENT THE TEMNO NEEDLE FROM GOING DOWN THE ASSOCIATED COAXIAL NEEDLE. THEREFORE, FAILURE MODE COULD BE CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. LOT #0001022711 WAS MANUFACTURED ON 25-NOV-2016. DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MOST PROBABLE ROOT CAUSE COULD BE RELATED TO ADHESIVE NOT BEING PROPERLY DISPENSED DUE TO PROCESS/ METHOD NOT DEFINED OR FOLLOWED APPROPRIATELY. THIS FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT TRACKING SYSTEM AND TRACKED & TRENDED FOR FUTURE OCCURRENCES OF ANY SIMILAR FAILURE MODES.

Additional Manufacturer Narrative

(B)(4). A FOLLOW UP SUBMISSION WILL BE DONE UPON COMPLETION OF CAREFUSIONS INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem

CUSTOMER REPORTED; SMALLER NEEDLE DID NOT FIT DOWN LARGER NEEDLE TO OBTAIN BX. AFTER NUMEROUS ATTEMPTS THE PATIENT BEGAN TO DEVELOP A PNEUMOTHORAX AND THE RADIOLOGIST STOPPED PROCEDURE WITHOUT BEING ABLE TO COLLECT A SAMPLE. PATIENT WAS HOSPITALIZED DUE TO PROCEDURE.