BD WHITACRE NEEDLE

Description of Event or Problem

CUSTOMER STATES THAT, THE NEEDLE BREAKAGE OCCURRED ON (B)(6) 2022, DURING A SPINAL ANESTHESIA PROCEDURE (OBESE PATIENT). SUBSEQUENTLY, IT WAS NECESSARY TO CALL IN THE SPINE SURGERY TEAM TO REMOVE THE TIP WITH THE AID OF FLUOROSCOPY (PROCEDURE WITHOUT COMPLICATIONS). AS THIS WAS AN ISOLATED EVENT, IT WAS DISCUSSED BY THE STANDARDIZATION COMMITTEE, AND IT WAS DECIDED TO MONITOR THE INCIDENCE OF THIS EVENT FOR SUBSEQUENT NOTIFICATION TO THE BD. I EMPHASIZE THAT THIS WAS THE ONLY EVENT AT THE INSTITUTION. THE PATIENT HAS NOW TAKEN LEGAL ACTION AGAINST THE INSTITUTION, ALLEGING SEQUELAE FROM THE INCIDENT. SALES TEAM STATES: ON 09/22/2022, PRIOR TO MY MANAGEMENT OF THE ACCOUNT, THERE WAS AN INCIDENT WITH OUR 408394 SPINAL ANESTHESIA NEEDLE - WHITACRE 27GA 3-1/2 NEEDLE - LOT: 2040557, IN WHICH THE TIP OF THE NEEDLE BROKE, REQUIRING SURGICAL INTERVENTION FOR REMOVAL, FORTUNATELY WITHOUT MAJOR DAMAGE TO THE PATIENT. AT THE TIME, THE HOSPITAL HANDLED THE CASE INTERNALLY AND DID NOT NOTIFY BD. RECENTLY, THE PATIENT FILED A LAWSUIT AGAINST THE HOSPITAL, AND THE CLIENT REQUESTS OUR SUPPORT TO UNDERSTAND IF THERE WERE OTHER OCCURRENCES RELATED TO THE LOT AND, IF POSSIBLE, A SUPPORTING DOCUMENT (SUCH AS A RESPONSE LETTER OR SIMILAR). ADDITIONAL INFORMATION RECEIVED ON 10OCT2025 EMAIL FOLLOW UP: REGARDING THE ADVERSE EVENT RELATED TO THE ¿SPINAL ANESTHESIA NEEDLE¿: THE REPORT STATED THAT, DURING THE ATTEMPT AT SPINAL ANESTHESIA, THE DISTAL PART OF THE NEEDLE BROKE, REQUIRING THE SPINE SURGERY TEAM TO BE CALLED IN TO REMOVE IT, WITH THE AID OF FLUOROSCOPY. AT THE MEETING, WE DISCUSSED THE DIFFICULTY OF IDENTIFYING THE ¿ROOT CAUSE¿ OF THE EVENT (QUALITY DEVIATION OR HANDLING FAILURE), SINCE WE HAD NO WAY OF EVALUATING THE TECHNIQUE USED OR THE MATERIAL SAMPLE. AND, CONSIDERING THAT THIS EVENT WAS UNIQUE AND ISOLATED, WE DECIDED TO CONTINUE MONITORING ANESTHETIC PROCEDURES FOR THE NEXT PERIOD.

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.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 408394 AND LOT NUMBER 2040557. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURES WERE PROVIDED; HOWEVER, THE PICTURES SHOWED THE UNIT PACKAGE LABEL INFORMATION. NO PICTURES SHOWING THE DEFECTIVE PRODUCT WERE AVAILABLE; THEREFORE, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. WITH THE PROVIDED EVENT DETAILS AND BASED ON THE PRODUCTS INTENDED USE, THINNER GAGES ARE RECOMMENDED TO BE USED WITH AN INTRODUCER NEEDLE, WHICH ASSISTS IN THE PLACEMENT OF SPINAL NEEDLES. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.