BONE MARROW BIOPSY NEEDLE, RBN-84 PN
Received Jan 4, 2022 · Event occurred Dec 6, 2021
Report 13151407 · MDR key 13151407
Device
Generic name
Instrument, Biopsy
Manufacturer
Ranfac Corp.Model number
8 GAUGE X 4Catalog number
RBN-84
Lot number
48402
Product problems
- Difficult to Remove
- Material Separation
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PATIENT PRESENTED TO (B)(6) CLINIC FOR BONE MARROW BIOPSY. PROCEDURE PROGRESSED SMOOTHLY. INSERTED JAMSHIDI NEEDLE INTO BONE AND CORED SAMPLE OF MARROW. UPON TRYING TO REMOVE THE JAMSHIDI NEEDLE, THE BLUE PLASTIC HANDLE BROKE AND SEPARATED FROM THE OUTER CORE NEEDLE. WHILE STERILE, I ATTEMPTED TO REMOVE THE NEEDLE BUT COULD NOT AT THIS TIME. PATIENT WAS INFORMED TO WHAT HAPPENED AND REMAINED CALM. PAGED ORTHO CONSULT SERVICE WHO SUGGESTED USING HEMOSTAT FOR REMOVAL WITH NEEDLE CORE IN PLACE TO PREVENT CRUSHING OF OUTER CORE. I DONNED STERILE GLOVES AND WAS HANDED CLEAN HEMOSTATS BY PATH TECH. APPLIED HEMOSTATS TO JAMSHIDI NEEDLE AND PULLED IN LINE WHILE ROTATING NEEDLE. NEEDLE CAME OUT OF BONE AND CORE MARROW SAMPLE WAS PRESERVED. PATIENT WAS CLEANED AGAIN WITH CHLORAPREP AND DRESSING WAS APPLIED TO BIOPSY SITE. PATIENT WAS GIVEN INSTRUCTIONS ON SIGNS AND SYMPTOMS OF INFECTION AND HOW TO REPORT TO PROVIDER. TOTAL TIME OF NEEDLE IN PELVIS WAS APPROXIMATELY 30 MINUTES, NO PROPHYLACTIC ANTIBIOTICS GIVEN. PATIENT THEN PROCEEDED TO RADIOLOGY FOR DXR: PELVIS TO ENSURE NO FOREIGN BODY LEFT IN PELVIS.