BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR SLANTS
Report
- Report Number
- 1119779-2022-01066
- Event Type
- Malfunction
- Date Received
- August 4, 2022
- Date of Event
- July 11, 2022
- Report Date
- September 18, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSJ
- UDI-DI
- 30382902209585
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: MATERIAL 220958 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE MEDIA IS THEN HEAT PROCESSED WITHIN A STERILIZATION MODULE PER STANDARD OPERATING PROCEDURE (SOP). HEAT SENSITIVE COMPONENTS ARE ADDED DURING FILLING. FILLING, CAPPING AND TORQUEING ARE PERFORMED WITHIN THE ASEPTIC PROCESSING AREA MECHANICALLY. ONCE THE SLANTS HAVE SOLIDIFIED, THE TUBES ARE THEN LABELED IN A SEPARATE PACKAGING AREA. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1182157 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION AND FILLING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. SAMPLES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR 28 DAYS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER OUR INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1182157 (10 TUBES) WERE AVAILABLE FOR INVESTIGATION. NO SUBSURFACE PARTICLES OR MICROBIAL GROWTH WAS OBSERVED IN 10/10 RETENTION SAMPLES. FOR INVESTIGATION OF THE COMPLAINT, THE RETENTIONS WERE INCUBATED FOR A 21-DAY INCUBATION PERIOD WITH THE CAPS LOOSENED. ONE RETENTION TUBE WAS PLACED INTO 33-37-DEGREE INCUBATION, AND ONE TUBE WAS PLACED INTO 20-25-DEGREE INCUBATION. NO MICROBIAL GROWTH OR SUB SURFACE PARTICLES WERE OBSERVED AFTER INCUBATION IN 2/2 RETENTION SAMPLES. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. COMPONENTS ARE PREPARED, COMBINED, AND DISPENSED ASEPTICALLY BUT THERE IS NO FINAL STERILIZATION STEP AFTER DISPENSING. THE MANUFACTURING PROCESS HAS BEEN DESIGNED TO MINIMIZE BIOBURDEN AND QC INSPECTION INCLUDES BIOBURDEN TESTING PRIOR TO RELEASE. ADDITIONALLY, IN-PROCESS INSPECTIONS ARE CONDUCTED DURING MANUFACTURING, AND PARTICLES OR FOREIGN MATERIALS ARE TO BE REJECTED PER PROCEDURES. HOWEVER, THERE IS NO GUARANTEE THAT THE END USER WILL NOT RECEIVE A CONTAMINATED TUBE OR THAT ALL TUBES WILL BE FREE OF DEFECTS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR SLANTS WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. ONE SLANT WAS AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS "A CONTAMINATED AGAR SLANT."
IT WAS REPORTED THAT BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR SLANTS WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. ONE SLANT WAS AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS "A CONTAMINATED AGAR SLANT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2133857 | BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR SLANTS | CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL | JSJ | BECTON, DICKINSON & CO. (SPARKS) | 220958 | 1182157 | 30382902209585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |