BD E-Z SCRUB

Additional Manufacturer Narrative

(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). SAMPLES AND PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION WAS DONE ON THE RETURNED 8 SAMPLES AND THE DISPENSER BOX. THE 8 SAMPLES WERE REVIEWED FOR SEAL BREACH AND ALL 8 SAMPLE SEALS APPEAR TO BE INTACT. THE DISPENSER BOX EXAMINED FOR SOAP RESIDUE AND NOTHING WAS FOUND. THE BAG THAT THE SAMPLES ARRIVED DID HAVE SMALL AMOUNTS OF SOAP RESIDUE. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. THE REVIEW OF THE RISK MANAGEMENT DOCUMENT SHOWS THAT THIS RISK IS ACCEPTABLE WITH POTENTIAL MODES OF FAILURE BEING LEAKING AND CUSTOMER DISSATISFACTION AND BOTH HAVE A LOW SEVERITY RATING. PRODUCTION RECORD REVIEW WAS COMPLETED WITH BATCH/LOT 0204987 AND NO DEVIATIONS/DISCREPANCIES THAT WOULD CAUSE OR CONTRIBUTE TO THIS ISSUE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

Description of Event or Problem

IT WAS REPORTED 5 PACKAGE WERE OPENED AND UNUSABLE. IT WAS CLARIFIED THAT THE FOAM CAME OUT OF THE SIDE OF THE PRODUCT PRIOR TO USE. 5 PACKAGES WERE OPENED AND UNUSABLE. CUSTOMER WOULD LIKE TO RECEIVE CREDIT OR REPLACEMENT. PER PHONE CALL: 5 FOAM CAME OUT OF THE SIDE OF THEM WHEN PULLED OUT OF THE PACKAGE. UNUSED SAMPLES AVAILABLE.