BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD
Report
- Report Number
- 1119779-2023-01505
- Event Type
- Malfunction
- Date Received
- January 14, 2024
- Date of Event
- December 13, 2023
- Report Date
- April 11, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- KZI
- UDI-DI
- 10382902212635
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER ADDRESS: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
PLEASE REFER TO THE 2ND PARAGRAPH OF THE MEMO, NEW INFORMATION WAS ADDED. H.6 INVESTIGATION SUMMARY : THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221263, PLATE COLUMBIA AGAR 5% SB 100 EA, BATCH NUMBER 3299061 AND BD COMPLAINT NUMBER (B)(4) FOR CONTAMINATION, BROKEN PLATES AND MISSING SLEEVE LABELS. DURING MANUFACTURING OF MATERIAL 221263, 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 3299061 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND 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 THE ONLY OTHER COMPLAINT ON BATCH 3299061 ALSO WAS TAKEN FROM AVAILS MEDICAL (COMPLAINT NUMBER 9388608 FOR LABELING). RETENTION SAMPLES FROM BATCH 3299061 WERE NOT AVAILABLE FOR INSPECTION. SEVENTEEN PHOTOS WERE RECEIVED FOR INVESTIGATION: NINE PHOTOS EACH SHOW THE SIDE OF A SLEEVE WITH ONE PLATE THAT HAS A SMALL, DARKENED (DARK BROWN) SECTION OF MEDIA. SIX PHOTOS EACH SHOW THE SIDE OF A SLEEVE WITH CRACKED LIDS OF SOME PLATES IN THE SLEEVE VISIBLE. ONE PHOTO SHOWS THE SIDE OF A SLEEVE WITH ONE CRACKED LID VISIBLE AND A SMALL, DARKENED SECTION OF MEDIA IN ANOTHER PLATE. ONE PHOTO FEATURES A SLEEVE LABEL FROM BATCH 3299061 FOR BATCH VERIFICATION. SEVERAL OF THE PHOTOS SHOW SLEEVES WITHOUT A SLEEVE LABEL VISIBLE. BIOLOGICAL CONTAMINATION WAS NOT DIRECTLY OBSERVED IN THE PHOTOS, HOWEVER, THE DARKENED MEDIA OBSERVED IN SOME OF THE PHOTOS COULD BE DUE TO MICROBIAL GROWTH IN THE MEDIA. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR BROKEN PLATES, MISSING SLEEVE LABEL AND CONTAMINATION. NO COMPLAINT TRENDS FOR THESE DEFECTS HAVE BEEN IDENTIFIED. NO ACTIONS ARE INDICATED AT THIS TIME PER BD PROCEDURES. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.
H.6 INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221263, PLATE COLUMBIA AGAR 5% SB 100 EA, BATCH NUMBER 3299061 AND BD COMPLAINT NUMBER (B)(4)FOR CONTAMINATION, BROKEN PLATES AND MISSING SLEEVE LABELS. DURING MANUFACTURING OF MATERIAL 221263, 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 3299061 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND 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 THE ONLY OTHER COMPLAINT ON BATCH 3299061 ALSO WAS TAKEN FROM AVAILS MEDICAL (COMPLAINT NUMBER (B)(4)FOR LABELING). RETENTION SAMPLES FROM BATCH 3299061 WERE NOT AVAILABLE FOR INSPECTION. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SIDE OF A SLEEVE WITH NO SLEEVE LABEL VISIBLE. THE OTHER THREE PHOTOS EACH SHOW THE SIDE OF A SLEEVE WITH CRACKED LIDS IN SOME OF THE PLATES. CONTAMINATION WAS NOT OBSERVED FROM THE PHOTOS PROVIDED. NO PRODUCT OR PLATE LABELS WERE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTOS CANNOT CONFIRM ANY DEFECTS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. H3 OTHER TEXT : SEE H.10
IT WAS REPORTED PRIOR TO USE THAT THE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD SLEEVE WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED PRIOR TO USE THAT THE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD SLEEVE WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED PRIOR TO USE THAT THE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD SLEEVE WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2003818 | BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD | CULTURE MEDIA, ENRICHED | KZI | BECTON DICKINSON & CO. (SPARKS) | 3299061 | 10382902212635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |