BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE)
Received Jan 19, 2023 · Event occurred Jan 16, 2023
Report 1119779-2023-00039 · MDR key 16206594
Device
Generic name
Supplement, Culture Media
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
212820
Lot number
1155481
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00039 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 WHILE USING THE BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE) THAT THERE WAS INSUFFICIENT GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS STATED THAT BACTERIAL GROWTH HAS BEEN INSUFFICIENT AFTER SWITCHING TO THE CURRENT LOT (1155481).
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE) THAT THERE WAS INSUFFICIENT GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS STATED THAT BACTERIAL GROWTH HAS BEEN INSUFFICIENT AFTER SWITCHING TO THE CURRENT LOT (1155481).