NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE
Received May 27, 2025 · Event occurred Apr 29, 2025
Report 2618282-2025-00042 · MDR key 22086972
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405138
Lot number
4304716
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
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 # 405138, BATCH # 4304716. IT WAS REPORTED BY CUSTOMER THAT WHEN ADVANCING SPINAL NEEDLE, IT SEPARATED AND WAS LODGED IN THE PTS SPINAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. ISSUE: WHEN ADVANCING SPINAL NEEDLE, IT SEPARATED AND WAS LODGED IN THE PTS SPINAL COLOMN. PT DID REQUIRE DIGANOSITCS AND SURGER TO REMOVE THE OTHER END. PT HARM: YES.
Description of Event or Problem
ADDITIONAL INFORMATION: THE PATIENT WAS IN OUR LABOR AND DELIVERY UNIT WHEN RECEIVING THE EPIDURAL. THE PATIENT NEEDED SURGERY TO REMOVE THIS NEEDLE THAT WAS LODGED INTO HER SPINE.
Additional Manufacturer Narrative
SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION WERE NOT BD SPINAL NEEDLES; THEREFORE, A SAMPLE ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.