NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: INITIAL REPORTER CITY. INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE HAVE RECENTLY MADE A CHANGE TO OUR 23G AND 25G SPINAL NEEDLE HANDLE COLORANTS IN ORDER TO BE IN COMPLIANT WITH ISO 6009.

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 #: 405180, BATCH#: UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REQUESTING IF THERE IS CHANGE IN THE QUINCKE SPINAL NEEDLE (REF 405180). STATES THE NEEDLE HUB WAS BLUE IN THE PAST AND NOW IT IS ORANGE. INQUIRING WHEN THAT CHANGE WAS MADE. ALSO, STATES THE DOCTORS ARE HAVING ISSUES USING THE NEEDLES. THEY HAVE TRIED SEVERAL DIFFERENT LOTS AND THEY STATE THERE IS A FLUID RESISTANCE WHEN THEY INJECT MEDICATIONS IN THE NEEDLE.