SPINAL NEEDLE 22GA 3.50IN FOR INDIA

Description of Event or Problem

RECEIVED COMPLAINTS FROM XXXXX THAT HIS CUSTOMER (DR. XXXXXX) HAS FACED CERTAIN ISSUES RELATED WITH OUR SPINAL NEEDLE 22G. WHILE INJECTING THE ANESTHETIC INTO THE SPINAL CORD, SHE HAS FACED SOME BLOCKAGE, AS THE MEDICINE WAS NOT REACHING TO THE DESTINY. THOUGH SHE HAS BEEN USING OUR SPINAL NEEDLE SINCE 2015, THIS IS THE FIRST TIME SHE FACE THIS ISSUE. HENCEFORTH COMPLAINT HAS BEEN RAISED TO UNDERSTAND WHY IT IS HAPPENING AND WHAT IS THE REASON BEHIND THE SAME. ADDITIONAL INFORMATION: DATE OF OCCURRENCE ¿ ALMOST 2 MONTHS AGO. WHAT COURSE OF TREATMENT CHANGED DUE TO EVENT? - WHILE OPERATING A PATIENT PREPARING FOR OPERATION. IS THERE ANY EXPOSURE OF BLOOD PATIENT BLOOD TO PATIENT OR HCP USER? ¿ NO SUCH INCIDENT HAPPENED. AS PER PIR, EXPOSURE TO BLOOD/BODILY FLUID - "UNKNOWN" PLEASE CONFIRM PATIENT HAD ANY HARM/INJURY? ¿ NO HARM/INJURY TO PATIENTS. IS THERE ANY MEDICAL INT. OTHER THAN FIRST AID? ¿ WAS NOT REQUIRED AS PER THE DISCUSSION IN THE PIR, ¿OTHER ACTIONS TAKEN¿ IS MARKED AS ¿UNKNOWN.¿ COULD YOU PLEASE EXPLAIN WHAT THESE OTHER ACTIONS ARE? ¿ OTHER ACTION PERFORMED BASIS ON THEIR EXPERIENCE, THEY SHIFTED FROM 22G TO 23G (OUR SPINAL ONLY). NOW THEY HAVE NO ISSUES.

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.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: MULTIPLE PHOTOS ALONG WITH TWO PHYSICAL SAMPLES, WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DAMAGE OR OTHER DEFECTS WERE OBSERVED ON ANY OF THE DEVICES. FUNCTIONAL TESTING WAS PERFORMED, LIQUID WAS ABLE TO MOVE THROUGH EACH NEEDLE WITHOUT ISSUE AND NO BLOCKAGE OR OTHER RESISTANCE WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2210007, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE INSPECTED, NO DAMAGE OR DEFECTS WITHIN THE NEEDLE WERE OBSERVED AND IT WAS VERIFIED THAT LIQUID COULD PASS THROUGH THE NEEDLE WITHOUT ISSUE, NO BLOCKAGE WAS OBSERVED. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THE NEEDLE IS FREE FROM DAMAGE AND ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. ALL INSPECTIONS FOR LOT 2210007 WERE COMPLETED ACCORDING TO PROCEDURE, NO ANNOTATIONS WERE NOTED RELATED TO THE REPORTED INCIDENT. 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 MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.