JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP

Description of Event or Problem

DURING A BONE MARROW BIOPSY PROCEDURE, WHEN A PHYSICIAN TOOK TISSUE FROM THE BIOPSY NEEDLE, A METAL PIECE CAME OUT WITH THE TISSUE FROM THE NEEDLE. THE METAL PIECE WAS TAKEN BY FORCEPS FROM THE FORMALIN SOLUTION. THE METAL PIECE WILL BE SENT WITH THE SAMPLE. THERE WAS NO INJURY OR MEDICAL INTERVENTION REQUIRED. ON (B)(6) 2013, THE INTERNATIONAL CONTACT ((B)(4)) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION AS OBTAINED FROM THE END USER: THERE WAS NOTHING NOTICED OF THE NEEDLE PRIOR TO USE THAT WOULD INDICATE A DEFECT AND THERE WAS NO DEFECT NOTED OF THE NEEDLE AFTER THE BIOPSY WAS TAKEN. THE BIOPSY PROCEDURE WAS NOT DIFFICULT IN ANY WAY AND THE BONE WAS NOT HARDER OR MORE RIGID THAN THE PHYSICIAN EXPECTED. ALSO, THE PHYSICIAN DID NOT FEEL HE NEEDED TO PLACE A LOT OF FORCE ON THE NEEDLE WHEN REPOSITIONING TO SEVERE THE SAMPLE AS INSTRUCTED IN THE PRODUCT¿S INSTRUCTIONS FOR USE.

Additional Manufacturer Narrative

(B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.