SPINAL/EPIDURAL NEEDLES & TRAYS

Additional Manufacturer Narrative

ADDITIONAL INFORMATION ADDED TO TAB B. CUSTOMER DID NOT RESPOND TO FOLLOW UP REQUESTING INFORMATION ON WHICH DATE CORRESPONDS TO THE NEED TO TRANSITION TO GENERAL ANESTHESIA. REVIEWED WITH INTERDISCIPLINARY DISCUSSION. IT HAS BEEN DECIDED TO DESIGNATE THIS MDR TO CAPTURE THE CHANGE TO REFLECT SERIOUS INJURY DUE TO THE TRANSITION TO GENERAL ANESTHESIA DESPITE NO HARM OCCURRING TO THE PATIENT.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 COULD YOU CLARIFY WHICH ANESTHETIC TECHNIQUE WAS USED FOLLOWING THE CHANGE FROM THE INITIALLY PLANNED SPINAL ANESTHESIA? WE OPTED TO CONVERT TO GENERAL ANESTHESIA IN ORDER TO ENSURE ADEQUATE CONDITIONS FOR PERFORMING THE SURGICAL PROCEDURE SAFELY. DID THIS CHANGE IN ANESTHETIC TECHNIQUE CAUSE ANY DELAY IN CARE, PROLONG THE RECOVERY TIME, OR EXTEND THE PATIENT¿S HOSPITAL STAY? THE EVENT DID NOT CAUSE ANY DELAY IN CARE, NOR DID IT PROLONG THE RECOVERY TIME OR THE HOSPITAL STAY.

Additional Manufacturer Narrative

H.3. 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

ACCORDING TO A COMPLAINT MADE BY OUR TEAM OF ANESTHESIOLOGISTS, THE TIP IS BROKEN IN HALF, LIKE A ¿DOUBLE TIP¿ OR SCISSOR TIP. ADDITIONAL INFORMATION RECEIVED ON 05 MAR 2026. IT WAS MENTIONED THAT ¿ACCORDING TO THE TEAM'S REPORT, THE SAME THING ALSO OCCURRED IN OTHER HOSPITALS THEY SERVE¿. COULD YOU CONFIRM THE NAME OF THE OTHER HOSPITAL WHERE THE REPORTED DEFECT OCCURRED? COULD YOU CONFIRM THE BATCH NUMBER INVOLVED AT THE OTHER HOSPITAL? ACCORDING TO WHAT WE HAVE BEEN TOLD BY OUR TEAM OF ANESTHESIOLOGISTS, THEY WILL ASK THE OTHER INSTITUTION TO NOTIFY YOU, PROVIDING THE REQUESTED INFORMATION. WHEN WAS THE PROBLEM/DEFECT IDENTIFIED: BEFORE, DURING OR AFTER USE? THE DEFECT WAS IDENTIFIED DURING THE USE OF THE MATERIAL, WHEN THE PUNCTURE FOR SPINAL ANESTHESIA WAS PERFORMED. IN VIEW OF THE TECHNICAL DIFFICULTY OBSERVED WITH THE FIRST NEEDLE, NEW UNITS FROM THE SAME BATCH WERE OPENED IN ORDER TO RULE OUT AN ISOLATED TECHNICAL FAULT. WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH? IF SO, EXPLAIN IN DETAIL. DURING THE PROCEDURE, UNUSUAL RESISTANCE TO THE NEEDLE'S PROGRESSION AND TECHNICAL DIFFICULTY IN PERFORMING THE PUNCTURE WERE OBSERVED, INCOMPATIBLE WITH THE USUAL PATTERN EXPECTED OF THE NEEDLE, LEADING TO SUSPICION OF MATERIAL NON-COMPLIANCE. MULTIPLE PUNCTURE ATTEMPTS WERE NECESSARY, WITHOUT INITIAL SUCCESS, WHICH RESULTED IN: INCREASED PAIN DURING THE PROCEDURE. FORMATION OF A HEMATOMA IN THE PUNCTURE AREA. THE NEED TO CHANGE THE ANESTHETIC TECHNIQUE INITIALLY PROPOSED, DUE TO THE IMPOSSIBILITY OF PROPERLY PERFORMING SPINAL ANESTHESIA WITH THIS MATERIAL. THE EVENT REQUIRED ANESTHETIC ADAPTATION IN ONE OF THE CASES IN ORDER TO GUARANTEE THE SAFETY AND PROPER MANAGEMENT OF THE PATIENT. THERE WERE NO RECORDS OF HEMODYNAMIC INSTABILITY OR IMMEDIATE NEUROLOGICAL COMPLICATIONS AT THE TIME OF THE POST-PROCEDURE EVALUATION. THE PATIENT REMAINED UNDER MONITORING AND FOLLOW-UP ACCORDING TO INSTITUTIONAL PROTOCOL.