BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
Report
- Report Number
- 1119779-2022-01307
- Event Type
- Malfunction
- Date Received
- October 17, 2022
- Date of Event
- October 6, 2022
- Report Date
- April 12, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 10382902217340
- PMA / PMN Number
- K803025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221734, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 2221411 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2221411 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2221411 WERE NOT AVAILABLE FOR INSPECTION. TWO HUNDRED PLATES FROM BATCH 2221411 WERE RETURNED AS 20 UNOPENED SLEEVES SHIPPED IN A RETAPED 100PACK CARTONS (CARTON NUMBERS 0564 AND 0910). PLATES WERE INSPECTED AND 4/200 PLATES HAD SURFACE BACTERIAL GROWTH (TIME STAMPS 0122, 0123, 1206, 1207). AFFECTED PLATES WERE SUBMITTED TO THE ID LAB AND LYSINIBACILLUS SPECIES WAS IDENTIFIED. SIX PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 2221411 (TIME STAMP 0812) WITH GROWTH VISIBLE. TWO PHOTOS EACH SHOW THE AGAR SURFACE OF A PLATE WITH A LARGE COLONY OF GROWTH. ANOTHER PHOTO FEATURES A SLEEVE LABEL FROM BATCH 2221411. THE FIFTH PHOTO FEATURES A PLATE PRINT FROM BATCH 2221411 (TIME STAMP 1207). THE LAST PHOTO SHOWS A CLOSE UP OF THE SIDE OF A SLEEVE TO FEATURE WHAT APPEARS TO BE GROWTH IN ONE OF THE PLATES. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT. H3 OTHER TEXT : SEE H.10
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THERE WAS ONE CONTAMINATED PLATE FOR BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATED PLATES IN LOT #2221411.
IT WAS REPORTED THAT THERE WAS ONE CONTAMINATED PLATE FOR BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATED PLATES IN LOT #2221411.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2224564 | BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221734 | 2221411 | 10382902217340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |