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 LOT # 4134383, 4015086 VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CALLER STATES THEY HAVE PRODUCT CODE 405180 WITH LOT#4134383 AND 4015086. CALLER STATES THAT THEY ARE LABELED DIFFERENTLY BY 1.1MM.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

THREE PHOTOS WERE PROVIDED BY THE CUSTOMER AS EVIDENCE FOR THIS INVESTIGATION. IT IS OBSERVED TWO (2) SHELF CARTONS OF 25GA NEEDLE (ONE (1) WITH BLUE LABEL AND ONE (1) WITH ORANGE LABEL). IN THE THIRD PHOTO IS SEEN THE TWO (2) SHELF CARTON ON THE SIDE SHOWING PART OF THE LABEL WITH THE CATALOG NUMBER AND THE NEEDLE MEASUREMENTS (IN THE BLUE LABEL THE MEASUREMENTS ARE IN METRIC SIZE (WHOLE NUMBERS) AND THE ORANGE LABEL ARE IN METRIC SIZE (DECIMAL NUMBERS). 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 WAS 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. ALSO, IN MAY 2024 A RESIN COLOR CHANGE IN THE HANDLE OF THE STYLET WAS IMPLEMENTED TO COMPLY WITH ISO STANDARDS.