JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP

Description of Event or Problem

THE DOCTOR INSERTED THE BONE MARROW NEEDLE IN THE ILIAC CREST, HOWEVER, THE NEEDLE WAS BROKEN IN TWO PIECES. ONE BROKEN PART WAS INSERTED IN THE PATIENT, THE OTHER WAS OUTSIDE.

Additional Manufacturer Narrative

SAMPLE WAS NOT AVAILABLE FOR COMPLAINT ANALYSIS; HOWEVER, PICTURES WERE SENT AND THE FAILURE COULD BE CONFIRMED. HOWEVER, THE EXACT CAUSE FOR THE ISSUE REPORTED COULD NOT BE DETERMINED. BASED ON SIMILAR REPORTS AND INVESTIGATION PREVIOUSLY PERFORMED, IT HAS BEEN DETERMINED THAT THE INSERTION ANGLE OF THE DJ DEVICE AT THE TIME OF PERFORMING THE BIOPSY PROCEDURE, IN COMBINATION WITH THE USE OF STROKES DIFFERENT THAN THOSE INDICATED IN THE INSTRUCTIONS FOR USE (DFU) FOR REMOVING THE DEVICE FROM THE BIOPSY SITE, COULD RESULT IN CANNULA DAMAGE (BREAKAGE OR BENDING). A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED SHOWED NO ISSUES DURING DOCUMENTATION REVIEW.

Additional Manufacturer Narrative

(B)(4). ONE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, IT WAS NOTED THAT THE NEEDLE WAS BROKEN IN TWO PIECES. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED SHOWED NO ISSUES DURING DOCUMENTATION REVIEW. BASED ON SIMILAR REPORTS AND INVESTIGATION PREVIOUSLY PERFORMED, IT HAS BEEN DETERMINED THAT THE INSERTION ANGLE OF THE DJ DEVICE AT THE TIME OF PERFORMING THE BIOPSY PROCEDURE, IN COMBINATION WITH THE USE OF STROKES DIFFERENT OF THOSE INDICATED IN THE INSTRUCTIONS FOR USE (DFU) FOR REMOVING THE DEVICE FROM THE BIOPSY SITE, COULD RESULT IN CANNULA DAMAGE (BREAKAGE OR BENDING).