BD BBL¿ BRAIN HEART INFUSION
Report
- Report Number
- 1119779-2023-00948
- Event Type
- Malfunction
- Date Received
- August 28, 2023
- Date of Event
- August 18, 2023
- Report Date
- October 10, 2023
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JSC
- UDI-DI
- 30382902208373
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: MATERIAL 220837 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED, AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCHES 3060897, 3005711, 3062729 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION AND FILLING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE REVIEW OF ITS COLOR AND CLARITY. SAMPLES SUBMITTED ARE EXAMINED TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. THE APPEARANCE OF THIS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. DIRECT STAINING TECHNIQUES ARE NOT PART OF QC RELEASE TESTING FOR THIS PRODUCT. ADDITIONALLY, AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCHES 306897, 3005711, AND 3062737. RETENTION SAMPLES FROM EACH BATCH 306897, 3005711, AND 3062737. (10 TUBES PER BATCH) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES FOR EACH BATCH. ALL RETENTION TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF CLEAR TO TRACE HAZY, LIGHT TO MEDIUM DARK YELLOW TAN AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS. FOR INVESTIGATION, TWO RETENTION TUBES OF EACH BATCH 306897, 3005711, AND 3062737 WENT INTO INCUBATION. FOR EACH BATCH IN QUESTION ONE RETENTION TUBE WAS PLACED INTO THE 20¿25-DEGREE CELSIUS INCUBATOR AND ONE RETENTION TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR. AT THE SEVENTH DAY OF INCUBATION THERE WERE NO SIGNS OF GROWTH OR TURBIDITY OR CHANGE IN MEDIA COLOR AND CLARITY. AFTER INCUBATION THE BROTH APPEARANCE REMAINED CLEAR TO TRACE HAZY, LIGHT TO MEDIUM DARK YELLOW AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAS BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. CAUTION SHOULD BE EXERCISED IN REPORTING DIRECT MICROBIOLOGICAL STAIN OR MOLECULAR TESTING DIRECTLY USING THIS MEDIUM DUE TO THE POSSIBLE PRESENCE OF NON-VIABLE ORGANISMS IN THE CULTURE MEDIUM. CULTURE MEDIA SOMETIMES CONTAIN DEAD ORGANISMS DERIVED FROM MEDIUM CONSTITUENTS, WHICH MAY BE VISIBLE IN SMEARS OF CULTURE MEDIA OR DETECTIBLE BY MOLECULAR TESTING. PRODUCT SHOULD NOT BE USED IF MEDIUM SHOWS EVIDENCE OF CONTAMINATION, DISCOLORATION, DRYING OR OTHER SIGNS OF DETERIORATION.
THERE WERE THREE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3005711. D4. MEDICAL DEVICE EXPIRATION DATE: 07-07-2024. H4. DEVICE MANUFACTURE DATE: 05-01-2023. D4. MEDICAL DEVICE LOT#: 3060897. D4. MEDICAL DEVICE EXPIRATION DATE: 25-08-2024. H4. DEVICE MANUFACTURE DATE: 01-03-2023. E.1. INITIAL REPORTER PREFIX: (B)(6). E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER FACILITY NAME: (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.
IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS BIOLOGICAL CONTAMINATION OF 100 TUBES ACROSS THREE BATCH NUMBERS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MICROSCOPIC CONTROL FROM A STERILE BOULLION REVEALED GRAM-NEGATIVE RODS."
IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS BIOLOGICAL CONTAMINATION OF 100 TUBES ACROSS THREE BATCH NUMBERS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MICROSCOPIC CONTROL FROM A STERILE BOULLION REVEALED GRAM-NEGATIVE RODS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286197 | BD BBL¿ BRAIN HEART INFUSION | CULTURE MEDIA, GENERAL NUTRIENT BROTH | JSC | BECTON DICKINSON & CO. (SPARKS) | 3062737 | 30382902208373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |