BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM
Received Apr 21, 2023 · Event occurred Apr 4, 2023
Report 3006260740-2023-01511 · MDR key 16792474
Device
Generic name
Needle, Hypodermic, Single Lumen
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
D001001
Lot number
N/A
Product problems
- Failure to Power Up
- Failure to Power Up
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. 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: FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE DRILL DOES NOT FUNCTION DUE TO AN INTERNAL FAILURE OF THE DRILL. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H11.
Description of Event or Problem
FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE DRILL DOES NOT FUNCTION DUE TO AN INTERNAL FAILURE OF THE DRILL.