WHITACRE SET 27GA 3-1/2IN
Received May 19, 2025 · Event occurred Apr 18, 2025
Report 3003152976-2025-00216 · MDR key 22045899
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405075
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
35 YR · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
EVENT DETAILS: NEEDLE BROKE DURING THE SPINAL ANESTHESIA PROCESS, LEAVING PART OF THE NEEDLE STUCK IN THE PATIENT.
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.
Additional Manufacturer Narrative
(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
NO ADDITIONAL INFORMATION.