NEEDLE SPINAL S/SU 20GA 6IN QUINCKE
Received Aug 27, 2024 · Event occurred Jun 24, 2024
Report 2618282-2024-00116 · MDR key 20075042
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405211
Lot number
4045038
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Insufficient Information
- Foreign Body In Patient
- Insufficient Information
Narrative
Description of Event or Problem
MATERIAL # 405211. BATCH # 4045038. IT WAS REPORTED BY CUSTOMER THAT NEEDLE BREAKING OFF INSIDE OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REP XXXXXX EMAILED TO REPORT PRODUCT B-D405211Z BREAKING OFF INSIDE OF HUB. CUSTOMER IS REQUESTING CREDIT FOR 1 BX OF ITEM.
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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.
Additional Manufacturer Narrative
NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. 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. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE: WITH ANY SPINAL PROCEDURE TO HELP AVOID NEEDLE BREAKAGE: DO NOT ATTEMPT TO STRAIGHTEN A BENT NEEDLE. CARE SHOULD BE TAKEN TO AVOID NEEDLE DAMAGE. REPEATED POSITIONING MAY INCREASE THE RISK OF NEEDLE BREAKAGE. OBSERVE NEEDLE CAREFULLY DURING PROCEDURES. REMOVE SPINAL NEEDLE AND INTRODUCER NEEDLE TOGETHER. REPLACE WITH A NEW NEEDLE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
Description of Event or Problem
NO ADDITIONAL INFORMATION.