BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM

Additional Manufacturer Narrative

THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THE INFORMATION, THE FOLLOWING WAS CONCLUDED: THE DEVICE WAS RETURNED TO SERVICE FACILITY FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF THERE IS A PIECE RATTLING INSIDE WAS CONFIRMED. THE DRILL WAS FOUND TO HAVE TWO ADDITIONAL MAGNETS INSIDE OF THE DRILL SOCKET DUE TO USE OF THE DEVICE.

Description of Event or Problem

NO ALLEGED DEFICIENCY, RETURN DUE TO IO DRILL RECALL. FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE DRILL WAS FOUND TO HAVE TWO ADDITIONAL MAGNETS INSIDE OF THE DRILL SOCKET DUE TO USE OF THE DEVICE.