NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THREE (3) 22GA X 3.5¿ UNUSED AND SEALED NEEDLES FOR BATCH NUMBER 4123761 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES WERE SUBMITTED FOR VISUAL INSPECTION FIRST. THERE WAS NO POINT DAMAGE, INCLUDING HOOKS, SWAGE MARKS, SCRATCHES, INCOMPLETE OR OPEN POINTS, UNSMOOTH GROUND SURFACES, DISCOLORATION OF ANY KIND OR SILVERS, AND NO PROTRUDERS, NO RECEDERS. THE NEEDLES WERE ALSO SUBMITTED TO TEST FOR ANY CLOGS OR BLOCKAGES. THE SAMPLES COMPLY WITH THE EXPECTED CHARACTERISTICS AND THE REPORTED FAILURE WAS NOT OBSERVED IN THE NEEDLES; THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED AS THE INCIDENT COULD NOT BE VERIFIED.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

Description of Event or Problem

MATERIAL# 405181 BATCH# 4123761 VERBATIM: I HAVE A HANDFUL OF THESE NEEDLES. REF 405181 22G X 3.50¿ LOT# 4123761 I AM TOLD THAT THESE HAVE BEEN ¿CLOGGING UP¿ WHEN BEING USED. THREE DIFFERENT STAFF MEMBERS HAVE STATED THIS. ADDITIONAL INFORMATION: DEC 20 IT HAPPENED MULTIPLE TIME (3+) FOR 3 DIFFERENT RADIOLOGISTS ON 3 DIFFERENT DAYS. NO PATIENT HARM.