BD MAX¿ ENTERIC BACTERIAL PANEL
Received Aug 14, 2023 · Event occurred Aug 7, 2023
Report 3007420875-2023-00074 · MDR key 17547477
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
442963
Lot number
3052425
Product problems
- Missing Information
- Missing Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USING BD MAX¿ ENTERIC BACTERIAL PANEL, ONE KIT ARRIVED WITHOUT A LABEL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGING IS NORMAL AND HAS NOT BEEN OPENED, BUT THERE ARE NO LABELS ON THE PACKAGING."
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3007420875-2023-00074 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USING BD MAX¿ ENTERIC BACTERIAL PANEL, ONE KIT ARRIVED WITHOUT A LABEL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGING IS NORMAL AND HAS NOT BEEN OPENED, BUT THERE ARE NO LABELS ON THE PACKAGING."
Additional Manufacturer Narrative
D.5. MEDICAL DEVICE TYPE: OOI, PCH. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.