NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

Additional Manufacturer Narrative

FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THE ISSUE REPORTED BY THE CUSTOMER WAS DUE TO AN ISO CHANGE AND THERE WAS NO MALFUNCTION OF BDS PRODUCT. THIS MDR WILL BE VOID.

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.

Description of Event or Problem

IN ONE PACKAGE IT APPEARS 88.9MM AND IN OTHERS 90MM, IS THIS MEASUREMENT CORRECT? IS IT A CHANGE OF MEASUREMENTS OR AN ERROR IN THE LABEL? IF WE GO BY THE MEASURES EXPRESSED IN THE HEALTH REGISTRATION WE WOULD HAVE THE FOLLOWING: 3.5 INCHES X 2.54 CM = 8.89 CM WOULD BE THE 88.9 MM OF THE SECOND LABEL.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED DATE OF EVENT IDENTIFIED? 05.SEP.2024. PLEASE CONFIRM THE QUANTITY AFFECTED. ALL LOTS OTHER THAN LOT 4113384. IS THERE ANY ISSUE FACED WITH THE PRODUCT OTHER THAN THE LABEL CONTENT INCORRECT? ONLY THE LABEL.

Additional Manufacturer Narrative

PHOTOS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED IN THE PHOTOS SHELF / CASE CARTONS WITH THE LABEL ADHERED WITH THE CATALOG NUMBER 405079 AND BATCH NUMBER, ALSO PHOTOS SHOW UNUSED AND SEALED NEEDLES IN THEIR BLISTER SHOWING THE TYVEK WITH VARIABLE DATA (CATALOG AND BATCH NUMBER, EXPIRATION DATE, NEEDLE LENGTH). IN THE PHOTOS CAN BE SEEN THE NEEDLE LENGTH IN WHOLE NUMBERS (0.4MM X 90MM) ¿ ENGLISH SIZE AND DECIMAL NUMBERS (0.4MM X 88.9MM) METRIC SIZE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. IN MAY 2024 IMPLEMENTED TO ALL LABELING LEVELS A UNIT CONVERSION FROM INCH TO MM IN NEEDLE LENGTH CONFIGURATIONS (DECIMAL NUMBERS). THIS CHANGE DID NOT IMPACT THE PRODUCT BECAUSE THE LENGTH OF THE NEEDLE IS THE SAME BUT, REFLECTED IN DECIMAL NUMBERS. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.