NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
Received Oct 29, 2025 · Event occurred Sep 30, 2025
Report 2618282-2025-00116 · MDR key 23413340
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Bd Caribe Ltd.Catalog number
405079
Lot number
4242354
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
EVENT DETAILS: A PIECE OF ITEM # 405079 X 1 EA LOT # 4242354 BROKE IN A PATIENT¿S BACK. INFORMATION BELOW: PATIENT STATUS = O.K., THEY RETRIEVED THE PIECE FROM THE PATIENT NO SAMPLES AVAILABLE TO RETURN ¿ THE REMAINING UNITS FROM THE LOT DISCARDED (THE PIECE WAS ALSO NOT AVAILABLE) CAN YOU PLEASE PROVIDE AN EXACT DATE OF THE EVENT IN THE FORMAT DD-MMM-YY? 30-09-2025 WAS ADDITIONAL SURGERY NEEDED TO REMOVE THE BROKEN NEEDLE? YES, AN ORTHOPEDIST CAME TO REMOVE THE NEEDLE. HAS THE INITIAL PROCEDURE BEEN COMPLETED? NO, THE PLANNED SURGERY HAD TO BE POSTPONED.
Additional Manufacturer Narrative
INITIAL MDR, IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
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. PER INVESTIGATION PERFORMED, CURRENT CONTROLS ARE ADEQUATE TO MITIGATE RISKS ASSOCIATED TO THE REPORTED FAILURE.
Description of Event or Problem
NO ADDITIONAL INFORMATION.