NEEDLE SP S/SU 25GA TW5IN WHITACRE CE

Additional Manufacturer Narrative

SAMPLE AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A PORTION OF A SPINAL NEEDLE WAS RECEIVED LOOSE INSIDE OF A ROUND, WHITE CYLINDER CONTAINER. IT IS OBSERVED A PORTION OF A NEEDLE, A BEND IN THE STEEL IS SEEN. IN THE PHOTOS, IT IS OBSERVED AN UNUSED 25GA (BLUE HUB) NEEDLE BESIDE THE BROKEN NEEDLE MISSING 4CM OF STEEL, ALSO IS SEEN THE TYVEK WITH THE CATALOG, BATCH NUMBER AND EXPIRATION DATE. 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. BASED ON PRODUCT INTENDED USE; THINNER GAGES ARE RECOMMENDED TO BE USED WITH AN INTRODUCER NEEDLE IN WHICH ASSISTS IN THE PLACEMENT OF SPINAL NEEDLES. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE. CARE SHOULD BE TAKEN TO AVOID NEEDLE DAMAGE. NOT ATTEMPTING TO STRAIGHTEN A BENT NEEDLE. REPEATED POSITIONING MAY INCREASE THE RISK OF NEEDLE BREAKAGE AND THEREFORE IT IS NOT RECOMMENDED. OBSERVE NEEDLE CAREFULLY DURING PROCEDURES AND TO BE USED BY PROPERLY QUALIFIED AND TRAINED HEALTH PROFESSIONALS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

NEEDLE BROKE IN PATIENTS BACK - PATIENT HAD TO HAVE SURGERY TO REMOVE THE NEEDLE.

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.