SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT WHEN ATTEMPTING TO DRAW BACK AND PRIME INCLUDED BD SAFETY GLIDE 25G X 1' NEEDLE WITH LIDOCAINE UNABLE TO ASPIRATE AIR THROUGH NEEDLE UNABLE TO EXPEL AIR OR PRIME NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN ATTEMPTING TO DRAW BACK AND PRIME INCLUDED BD SAFETY GLIDE 25G X 1' NEEDLE WITH LIDOCAINE UNABLE TO ASPIRATE AIR THROUGH NEEDLE UNABLE TO EXPEL AIR OR PRIME NEEDLE.

Additional Manufacturer Narrative

(B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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. H3 OTHER TEXT : SEE MANUFACTURE NARRATION.