BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM

Description of Event or Problem

NO ALLEGED DEFICIENCY, RETURN DUE TO IO DRILL RECALL FOUND DURING EVALUATION AT BD SERVICE FACILITY: A SMALL DISC MAGNET WAS FOUND IN THE CHUCK OF THE DRILL. THE MAGNET WAS REMOVED AND THE DRILL IS FUNCTIONING PROPERLY.

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 THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE DEVICE WAS RETURNED TO THE SERVICE FACILITY FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF FAILURE TO POWER ON IS CONFIRMED. A SMALL DISC MAGNET WAS FOUND IN THE CHUCK OF THE DRILL. THE MAGNET WAS REMOVED AND THE DRILL IS FUNCTIONING PROPERLY.