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

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. IT WAS REPORTED BY CUSTOMER THAT PLEASE ADVISE IF THE ITEMS SHOWN IN THE PICTURE IS SAME. ONE IS BLUE AND THE OTHER IS RED AND THE ITEM NO. IS SAME FOR BOTH. QUINCKE SPINAL NEEDLE 405180. PLEASE ADVISE IF THE ITEMS SHOWN IN THE PICTURE IS SAME. ONE IS BLUE AND THE OTHER IS RED AND THE ITEM NO. IS SAME FOR BOTH. QUINCKE SPINAL NEEDLE 405180.

Additional Manufacturer Narrative

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. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

Description of Event or Problem

NO ADDITIONAL INFORMATION.