SPINAL NEEDLE 25GA 3.50IN FOR INDIA

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

DESCRIPTION: DR'S (BOTH ANESTHESIOLOGIST) HAD 3 COMPLAINTS FOR SPINAL NEEDLE 25G. 1. SLUGGISH AND SLOW FLOW OF CSF EVEN ASPIRATION OF CSF IS VERY HARD AND ANESTHESIA PUSH IS VERY RELUCTANT. 2. BLUNT FROM THE TOP. 3. ONSET OF ACTION OF BUPIVACAINE 5MG IS DELAYED. PER RESPONSE: ANS 1 AND 2 - AFTER INJECTING MEDICATION DOCTOR GOT DELAYED RESPONSE OF MEDICATION. THEY ARE USING BUPIVACAINE 5MG GENERALLY THEY GET RESPONSE FASTER AND LOSS OF SENSATIONS HAPPEN FASTER BUT WITH OUR PRODUCT THEY ARE GETTING DELAYED RESPONSE. ANS 3 - THEY WERE ABLE TO INJECT MEDICINE, BUT THEY FELT GREAT RESISTANCE AND THEY HAD TO PUSH HARD WHILE INJECTING MEDICINE. NO PATIENT HARM.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. TWO PHOTOS WHICH CONFIRM THE MATERIAL INFORMATION HAVE BEEN RECEIVED AS WELL AS A VIDEO WHICH DISPLAYS HOW THE ANESTHESIA IS INJECTED USING THE SPINAL NEEDLE. NO DAMAGE ON THE DEVICE OR ISSUE RELATED TO THE FLOW OF MEDICATION CAN BE IDENTIFIED FROM THE VIDEO. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2407020. 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 2407020 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.