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 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. THE DRILLS TRIGGER IS INTERMITTENTLY UNRESPONSIVE DUE TO AN INTERNAL FAILURE WITHIN THE DRILL.

Description of Event or Problem

NO ALLEGED DEFICIENCY, RETURN DUE TO IO DRILL RECALL. FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE DRILLS TRIGGER IS INTERMITTENTLY UNRESPONSIVE DUE TO AN INTERNAL FAILURE WITHIN THE DRILL.