SPINAL/EPIDURAL NEEDLES & TRAYS
Received Oct 23, 2025 · Event occurred Sep 25, 2025
Report 9610048-2025-00151 · MDR key 23364430
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
401383
Lot number
5141389
Product problems
- Crack
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 401383 AND LOT NUMBER 5141389. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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
ADDITIONAL INFORMATION 20-OCTOBER-2025: DUE TO THE OCCURRENCE, WE INFORM THAT: A NOTIFICATION PROCESS WAS OPENED WITH ANVISA 2025.09.005566, AS REQUIRED BY CURRENT LEGISLATION. THE PRODUCT SHOWS CHANGES: CRACKING, BREAKAGE OF THE PRODUCT OR PART OF IT. WAS THE PRODUCT INSPECTED BEFORE USE? - YES DID THE PROBLEM OCCUR BEFORE, DURING, OR AFTER CONTACT WITH THE PATIENT? - DURING WHAT PROCEDURE WAS PERFORMED AND ON WHICH PART OF THE BODY? - LUMBAR SPINE EQUIPMENT USED? - NO. WAS THE PATIENT HARMED? - NO. WAS THE MATERIAL USED UNTIL THE END OF THE PROCEDURE OR WAS IT NECESSARY TO REQUEST A NEW ONE TO COMPLETE IT? - NO, ANOTHER MATERIAL WAS NEEDED. WAS THE MATERIAL USED UNTIL THE END OF THE PROCEDURE OR WAS IT NECESSARY TO REQUEST A NEW ONE TO COMPLETE IT? - NO.
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. E1. ALL DEMOGRAPHIC INFORMATION ON THE REGULATORY DOCUMENT STATES "CONFIDENTIAL".
Description of Event or Problem
IT WAS REPORTED THAT THE KIT CONTAINS TWO NEEDLES. WHEN USING THE 3 ML NEEDLE, IT EXERTED EXCESSIVE PRESSURE WHEN ADMINISTERING THE ANESTHETIC, CAUSING THE NEEDLE TO RICOCHET AND RESULTING IN A MINOR INJURY TO THE PATIENT. WHEN OPTING TO USE THE 5 ML NEEDLE, IT WAS CRACKED, CAUSING THE MEDICATION TO LEAK DURING INFUSION.