NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
Received Aug 11, 2025 · Event occurred Jun 15, 2025
Report 2618282-2025-00084 · MDR key 22776560
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405180
Lot number
4257390
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT LEAKAGE. EVENT DESCRIPTION: I DO HAVE (B)(4) MORE INCIDENTS ON A LIST OF LEAKING DATES/LOT #. HOWEVER, I DIDN'T KNOW OF THE TIME LIMIT TO KEEP THE COMPLAINT OPEN. ADDITIONAL INFORMATION 1. AS MENTIONED, THERE ARE TWO MORE INCIDENTS RELATED TO LEAKAGE. COULD YOU PLEASE PROVIDE THE EXACT DATES OF THESE EVENTS IN THE MM-DD-YYYY FORMAT? (B)(6) 2025. (B)(6) 2025. 2. PLEASE SHARE THE MATERIAL & LOT NUMBER ASSOCIATED WITH REPORTED ISSUE LOT # IS THE SAME FOR BOTH DATES. CAME FROM THE SAME BOX. (B)(6). SKU# 405180. BD 25G X 3.5" QUINCKE SPINAL NEEDLES. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM/INJURY. COMPLICATION/NEGATIVE OUTCOME IS THAT THE WITH THE LEAKING HUB AREA, THE PROVIDER FEELS THAT THE FULL DOSAGE OF THE MEDICATION DID NOT REACH THE INTENDED AREA. THE PROVIDER DOES READJUST THE SYRINGE/NEEDLE CONNECTION TO VERIFY FULL CONTACT IS INTACT. (B)(6) 2025 PATIENT WAS A CERVICAL MEDIAN BRANCH BLOCK. (B)(6) 2025 PATIENT WAS A LUMBAR MEDIAN BRANCH BLOCK. 4. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHYSICAL SAMPLE IS AVAILABLE AS USED/DIRTY NEEDLES ARE PLACED IN THE SHARPS BUCKET AFTER THE PROCEDURE. 5. HOW MANY PATIENTS WERE AFFECTED BY THE REPORTED LEAKS? (B)(4). 6. ARE INDIVIDUAL EVENT DATES AVAILABLE FOR EACH OF THE REPORTED OCCURRENCES? IF YES, PLEASE PROVIDE THE DATES. (B)(6) 2025. (B)(6) 2025.
Additional Manufacturer Narrative
H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.