WHITACRE 24GA 3-1/2IN

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

MATERIAL# 405133, BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT WHEN INSERTING THE WHITAKER NEEDLE (SN24) INTO THE SPINAL INTRODUCER NEEDLE (N2OI) THAT IT WAS VERY TIGHT AND THEREFORE CAUSED DIFFICULTIES WHEN TRYING TO PERFORM THE LP VERBATIM: WHEN INSERTING THE WHITAKER NEEDLE (SN24) INTO THE SPINAL INTRODUCER NEEDLE (N2OI) THAT IT WAS VERY TIGHT AND THEREFORE CAUSED DIFFICULTIES WHEN TRYING TO PERFORM THE LP. AS YOU CAN APPRECIATE THIS DID NOT MAKE THE LP PROCEDURE VERY COMFORTABLE FOR THE PARTICIPANT. IN THE KIT ACCESSION NUMBER (B)(6), ALL 3 NEEDLES AND BOTH INTRODUCER NEEDLES WERE USED AND THE ISSUE WAS STILL OCCURRING.

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2105008, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. RETAINED SAMPLES FROM THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS THOROUGHLY INSPECTED, NO MARKS, SCRATCHES, DAMAGE, FRICTION, OR OTHER DEFECTS WERE IDENTIFIED ON THE PRODUCTS. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. ALL LOT RELEASE TESTING WAS REVIEWED AND FOUND PRODUCT MET REQUIREMENTS; NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE CANNOT DETERMINED 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

MATERIAL# 405104 BATCH #2105008. VERBATIM: WHEN INSERTING THE WHITAKER NEEDLE (SN24) INTO THE SPINAL INTRODUCER NEEDLE (N2OI) THAT IT WAS VERY TIGHT AND THEREFORE CAUSED DIFFICULTIES WHEN TRYING TO PERFORM THE LP. AS YOU CAN APPRECIATE THIS DID NOT MAKE THE LP PROCEDURE VERY COMFORTABLE FOR THE PARTICIPANT. IN THE KIT ACCESSION NUMBER 6222721686, ALL 3 NEEDLES AND BOTH INTRODUCER NEEDLES WERE USED AND THE ISSUE WAS STILL OCCURRING. PER EMAIL RECEIVED 30JUL2024: ¿ AVAILABILITY OF IMPACTED NEEDLES TO RETURN: THE SITE DID NOT KEEP THE IMPACTED NEEDLES SO THESE CANNOT BE RETURNED ¿ DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. FROM THE PATIENT POINT OF YOU, THE ISSUE DID NOT RESULT IN INJURIES. HOWEVER, IT WAS VERY PAINFUL. DESPITE THE LOCAL ANESTHESIA, THE PATIENT FELT WHAT WAS HAPPENING IN HIS BACK. HE UNDERSTOOD THAT SOMETHING WAS WRONG. THE PHYSICIAN THOUGHT HE HAD NOT PERFORMED THE LP WELL AND REMOVED THE GUIDE FROM THE BACK AND NOTICING THAT OUTSIDE THE BODY IT WAS THE SAME. THE STUDY TEAM MANAGED THE SITUATION WITH CALM AND PROFESSIONALISM. THE PATIENT WAS TOTALLY STRESSED AND ASKED FOR TIME TO RECOVER BEFORE THE SECOND ATTEMPT. WITH THE NEXT GUIDE AND NEEDLE, THE TEAM TESTED THE WHOLE SETUP BEFORE THE INJECTION AND IT WAS THE SAME, IT JAMMED TOO BUT THE SUB-I PASSED THOUGH AND PATIENT RECEIVED THE IMP. PER EMAIL 21AUG2024: 1. PLEASE SHARE THE MATERIAL & LOT NUMBER? A. NEEDLE SP S/SU 24GA TW 3 1/2IN WHITACRE: LOT 2105008.

Description of Event or Problem

MATERIAL# 405104 BATCH #2105008. MATERIAL NUMBER AND BATCH UPDATED.

Additional Manufacturer Narrative

FOLLOW UP MDR FOR ADDITIONAL INFORMATION RECEIVED. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, WE RECEIVED INFORMATION THAT THE INCORRECT PRODUCT INFORMATION WAS PROVIDED. CUSTOMER SUPPLIED CORRECT INFORMATION. MATERIAL NUMBER, BATCH, EXPIRATION DATE, CREATION DATE, MEDICAL DEVICE BRAND NAME CORRECTED IN SECTION D.