SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE USED FOR LIDOCAINE ADMINISTRATION FOR LP WAS OCCLUDED. UNABLE TO PUSH AIR OR LIDOCAINE THROUGH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE USED FOR LIDOCAINE ADMINISTRATION FOR LP WAS OCCLUDED. UNABLE TO PUSH AIR OR LIDOCAINE THROUGH.

Additional Manufacturer Narrative

(B)(4) INITIAL EMDR SUBMISSION. DEVICE PROBLEM CODE: A140901. PATIENT PROBLEM CODE: F24. 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.