PEDIATRIC LUMBAR PUNCTURE TRAY

Additional Manufacturer Narrative

ON MARCH 18, 2025 WE RECEIVED A REPORT INVOLVING BUSSE CATALOG 646B. IN THE EMAIL, THE FOLLOWING INFORMATION WAS SUBMITTED: INCIDENT DESCRIPTION: WHILE PREPARING FOR A LUMBAR PUNCTURE ON A PATIENT, THE DOCTOR WAS ADMINISTERING LOCAL ANESTHESIA USING THE 25 GAUGE X 5/8" NEEDLE AND 3 CC LEUR LOCK SYRINGE, WHICH WERE PROVIDED WITH THE LUMBAR PUNCTURE SET. UPON REMOVING THE NEEDLE, IT WAS DISCOVERED THAT THE NEEDLE HAD DETACHED AND WAS LEFT INSIDE THE PATIENT'S SKIN, REQUIRING AN ADDITIONAL SURGICAL PROCEDURE FOR REMOVAL. DEVICE INFORMATION: -DEVICE: PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY. -MANUFACTURER: BUSSE HOSPITAL DISPOSABLES. -MODEL: 646B. -LOT NUMBER: 2310367. -LOCATION: SECURITY FORCES HOSPITAL PROGRAM - (B)(6). THE CUSTOMER REQUESTED AN INVESTIGATION AND TO KNOW WHETHER THERE HAVE BEEN OTHER SIMILAR REPORTS. IMMEDIATELY, ON (B)(6) 2025 UPON BECOMING AWARE OF THE REPORT, BUSSE ISSUED A COMPLAINT TO INVESTIGATE THE ISSUE. COMPLAINT # (B)(4) WAS ASSIGNED. THE REPORT WAS ACKNOWLEDGED WITH THE CUSTOMER, BY RESPONDING TO THE QUESTIONS POSTED AND PROVIDING AN ACKNOWLEDGEMENT LETTER. AT THE TIME BUSSE CONFIRMED THAT WE HAVE NOT RECEIVED ANY PREVIOUS REPORTS ON THIS CATALOG OR COMPONENT RELATED TO THE REPORTED ISSUE. ON THAT SAME DAY, BUSSE POSTED THE FOLLOWING QUESTIONS TO THE CUSTOMER: DID THE NEEDLE (CANNULA PORTION) DETACHED FROM THE EXPOSITED CONNECTION OF THE HUB OR DID IT BREAK AT THE HUB? DID THE NEEDLE CANNULA BREAK? WHAT PROCESS WAS BEING DONE AT THE TIME OF THE DETACHMENT? HOW DEEP WAS THE NEEDLE INSERTED? WAS THE NEEDLE INSERTED IN AN ANGLE? ON THE SAME DAY, CUSTOMER REPLIED AS FOLLOWED: YES, THE NEEDLE DETACHED FROM THE SYRINGE HUB, NEITHER PENDED NOR BROKEN (EVIDENCE PROVIDED). PHYSICALLY IT LOOKS NOT BROKEN. INJECTING LIDOCAINE LOCAL ANESTHESIA SUBCUTANEOUSLY. SUBCUTANEOUSLY. YES, BY ANESTHESIA CONSULTANT. INVESTIGATION SUMMARY: NEEDLE BREAKAGE COMPLAINT. ON (B)(6), BUSSE CONDUCTED A STOCK INSPECTION FOLLOWING A REPORTED ISSUE RELATED TO A CONTROL LOT. WHILE THE SPECIFIC CONTROL LOT REFERENCED IN THE REPORT WAS NO LONGER AVAILABLE FOR EVALUATION, ALL OTHER AVAILABLE STOCK WAS INSPECTED AND FOUND TO BE IN FULL COMPLIANCE WITH ESTABLISHED QUALITY ASSURANCE REQUIREMENTS. FURTHER INVESTIGATION DETERMINED THAT (B)(4) NEEDLES HAD BEEN RELEASED UNDER CONTROL NUMBER #(B)(4), WITH NO ADDITIONAL COMPLAINTS OF BREAKAGE REPORTED. BASED ON THIS INFORMATION, THE INCIDENT IS CURRENTLY CLASSIFIED AS ISOLATED. HOWEVER, BUSSE IS STILL AWAITING THE DEFECTIVE SAMPLE AND THE MANUFACTURER'S FEEDBACK TO FINALIZE THE INVESTIGATION. THE INVESTIGATION INCLUDED A COMPREHENSIVE REVIEW OF ALL PRODUCTION AND QUALITY INSPECTION RECORDS ASSOCIATED WITH BOTH THE KIT AND THE SPECIFIC NEEDLE COMPONENT. NO DEVIATIONS FROM STANDARD MANUFACTURING OR QUALITY CONTROL PROCEDURES WERE IDENTIFIED. ADDITIONALLY, A RE-INSPECTION OF THE CURRENT STOCK CONFIRMED COMPLIANCE WITH ALL QUALITY STANDARDS. VENDOR/MANUFACTURER INVESTIGATION: ON (B)(6), THE NEEDLE'S MANUFACTURER WAS FORMALLY NOTIFIED OF THE ISSUE, AND AN INDEPENDENT INVESTIGATION WAS REQUESTED. THE MANUFACTURER PROVIDED A RESPONSE AND CONCLUSION ON (B)(6). BASED ON A REVIEW OF PRODUCT RECORDS AND TESTING OF AVAILABLE SAMPLES, THE MANUFACTURER REPORTED NO ABNORMALITIES IN PRODUCTION OR QUALITY CONTROL. ADDITIONALLY, AN EVALUATION OF PHOTOGRAPHIC EVIDENCE SUBMITTED WITH THE COMPLAINT LED TO THE MANUFACTURER'S CONCLUSION THAT THE PRODUCT WAS NOT DETACHED, AS INITIALLY REPORTED, BUT RATHER BROKEN. THE MANUFACTURER STATED: "DUE TO THE BENDING OF THE NEEDLE TUBE UNDER THE ACTION OF EXTERNAL FORCE DURING USE, THE BENDING ANGLE MAY EXCEED 20°, WHICH MAY RESULT IN DAMAGE AND BREAKAGE OF THE NEEDLE TIP. THEREFORE, THIS COMPLAINT IS NOT ATTRIBUTED TO A QUALITY ISSUE." FURTHERMORE, THE MANUFACTURER RECOMMENDED THAT CLINICAL STAFF ADHERE STRICTLY TO OPERATIONAL GUIDELINES, SPECIFYING THAT "THE BENDING ANGLE OF THE NEEDLE SHOULD NOT EXCEED 20° DURING INJECTION TO PREVENT DAMAGE AND BREAKAGE THAT COULD IMPACT CLINICAL USE." CONCLUSION: AS OF THIS REPORT, NO PHYSICAL SAMPLE HAS BEEN PROVIDED FOR FURTHER EXAMINATION, LIMITING THE SCOPE OF ADDITIONAL INVESTIGATION. GIVEN THAT THIS IS THE FIRST RECORDED COMPLAINT OF THIS NATURE IN OUR DATABASE AND NO MANUFACTURING DEFECTS HAVE BEEN IDENTIFIED, THE INCIDENT IS CONSIDERED ISOLATED. BUSSE SUPPORTS THE MANUFACTURER'S CONCLUSION THAT THE ISSUE LIKELY RESULTED FROM USER HANDLING RATHER THAN A QUALITY DEFECT.

Description of Event or Problem

USER REPORTS THE FOLLOWING: WHILE PREPARING FOR A LUMBAR PUNCTURE ON A PATIENT, THE DOCTOR WAS ADMINISTERING LOCAL ANESTHESIA USING THE 25 GAUGE X 5/8" NEEDLE AND 3 CC LEUR LOCK SYRINGE, WHICH WERE PROVIDED WITH THE LUMBAR PUNCTURE SET. UPON REMOVING THE NEEDLE, IT WAS DISCOVERED THAT THE NEEDLE HAD DETACHED AND WAS LEFT INSIDE THE PATIENT'S SKIN, REQUIRING AN ADDITIONAL SURGICAL PROCEDURE FOR REMOVAL.