BD DIFCO¿ AGAR, GRANULATED
Received Jun 6, 2022 · Event occurred May 9, 2022
Report 1119779-2022-00820 · MDR key 14604647
Device
Generic name
Supplement, Culture Media
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
214530
Lot number
0139161
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
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 DURING USE WITH BD DIFCO¿ AGAR, GRANULATED THERE WAS ALTERED PHENOTYPIC GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ALTERED PHENOTYPIC GROWTH WITH THEIR 214530 AGAR FROM LOT 0139161. CUSTOMER STATES AGAR IS PRODUCING AN ALTERED GROWTH PHENOTYPE FOR ONE OF THEIR ORGANISMS. WHEN LB AND TSA PLATES MADE WITH THIS AGAR ARE USED TO CULTURE SALMONELLA ENTERICA SUBSP ENTERITIDIS, S. ENTERITIDIS DISPLAYS A STRESS-ASSOCIATED, FILAMENTOUS CELLULAR MORPHOLOGY (DETERMINED BY GRAM STAINING) AND IRREGULAR COLONY MORPHOLOGY (INCONSISTENT COLONY SIZE AND COLOR). CUSTOMER HAS TESTED A VARIETY OF POSSIBLE SOURCES, INCLUDING THE WATER, GLASSWARE, AUTOCLAVE, AND NUTRIENT SOURCE, AND ARE CONFIDENT IN OUR ASSESSMENT THAT THE ISSUE IS CAUSED BY THIS LOT OF DIFCO AGAR. USING A DIFFERENT LOT NUMBER OF THE SAME PRODUCT DOES NOT REPRODUCE THIS ISSUE. CUSTOMER ALSO TRIED OTHER ORGANISMS ON THE SAME MEDIA AND SAW TYPICAL GROWTH. CUSTOMER WANTED TO REACH OUT AND INFORM BD THAT THERE MAY BE AN ISSUE WITH THIS LOT. SINCE THE ISSUE WAS ONLY OBVIOUS WITH SOME SPECIES OF BACTERIA AND NOT OTHERS, THE ISSUE MIGHT BE HAVING ¿INVISIBLE¿ EFFECTS ON EXPERIMENTAL OUTCOMES, OR MAY HAVE RESULTED IN DATA THAT IS NOT RELIABLE OR REPLICABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD DIFCO¿ AGAR, GRANULATED THERE WAS ALTERED PHENOTYPIC GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ALTERED PHENOTYPIC GROWTH WITH THEIR 214530 AGAR FROM LOT 0139161. CUSTOMER STATES AGAR IS PRODUCING AN ALTERED GROWTH PHENOTYPE FOR ONE OF THEIR ORGANISMS. WHEN LB AND TSA PLATES MADE WITH THIS AGAR ARE USED TO CULTURE SALMONELLA ENTERICA SUBSP ENTERITIDIS, S. ENTERITIDIS DISPLAYS A STRESS-ASSOCIATED, FILAMENTOUS CELLULAR MORPHOLOGY (DETERMINED BY GRAM STAINING) AND IRREGULAR COLONY MORPHOLOGY (INCONSISTENT COLONY SIZE AND COLOR). CUSTOMER HAS TESTED A VARIETY OF POSSIBLE SOURCES, INCLUDING THE WATER, GLASSWARE, AUTOCLAVE, AND NUTRIENT SOURCE, AND ARE CONFIDENT IN OUR ASSESSMENT THAT THE ISSUE IS CAUSED BY THIS LOT OF DIFCO AGAR. USING A DIFFERENT LOT NUMBER OF THE SAME PRODUCT DOES NOT REPRODUCE THIS ISSUE. CUSTOMER ALSO TRIED OTHER ORGANISMS ON THE SAME MEDIA AND SAW TYPICAL GROWTH. CUSTOMER WANTED TO REACH OUT AND INFORM BD THAT THERE MAY BE AN ISSUE WITH THIS LOT. SINCE THE ISSUE WAS ONLY OBVIOUS WITH SOME SPECIES OF BACTERIA AND NOT OTHERS, THE ISSUE MIGHT BE HAVING ¿INVISIBLE¿ EFFECTS ON EXPERIMENTAL OUTCOMES, OR MAY HAVE RESULTED IN DATA THAT IS NOT RELIABLE OR REPLICABLE.
Additional Manufacturer Narrative
THIS MDR SHOULD BE CONSIDERED CANCELLED. THIS PRODUCT WAS DETERMINED TO BE FOR LAB USE ONLY AND IS NOT SOLD AS A MEDICAL DEVICE IN THE US. THIS COMPLAINT HAS BEEN DETERMINED TO BE NOT REPORTABLE.