NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
Received Dec 11, 2024 · Event occurred Nov 27, 2024
Report 2618282-2024-00186 · MDR key 20901864
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405180
Lot number
UNKNOWN
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
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#: 405180, BATCH#: UNKNOWN. SINCE THE ANESTHESIA NEEDLES HAVE CHANGED TO ORANGE, THERE IS NOW LEAKING AT THE HUB WHEN INJECTING LIPIODOL.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: A COMPLAINT HISTORY RECORD(CHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A DEVICE HISTORY REVIEW WAS UNABLE TO BE PERFORMED SINCE NO LOT/BATCH NUMBER WAS PROVIDED. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE AND BATCH/LOT NUMBER INFORMATION.
Description of Event or Problem
ADDITIONAL INFORMATION: WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.