NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
Received Dec 26, 2024 · Event occurred Dec 13, 2024
Report 2618282-2024-00193 · MDR key 21019274
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405180
Lot number
4211030
Product problems
- Complete Blockage
- Complete Blockage
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 NUMBER#: 4211030. VERBATIM#: A DOCTOR WAS USING BD NEEDLES, REF# 405180, AND FOUND THE NEEDLES TO BE CLOGGED. SHE TRIED SEVERAL AND THEY DID NOT WORK AND CHECKED THE SYRINGES WHICH WERE OK. THE FAULTY ONES WERE IN LOT # 4211030. WE HAVE 21 UNOPENED NEEDLES FROM ONE OPENED BOX. WE HAVE 6 MORE BOXES OF 25 UNOPENED OF THAT SAME LOT NUMBER. NO PATIENT HARM.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: 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.