BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)
Report
- Report Number
- 1119779-2022-00567
- Event Type
- Malfunction
- Date Received
- April 15, 2022
- Date of Event
- March 23, 2022
- Report Date
- October 18, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 30382902218235
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY:MATERIAL 221823 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.BATCH 2019003.THE BATCH HISTORY RECORD REVIEW FOR BATCH 2019003 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING 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. 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 THIS BATCH FOR ANY DEFECT. RETENTION SAMPLES FROM BATCH 2019003 (10 TUBES) WERE AVAILABLE FOR INVESTIGATION. EACH RETENTION TUBE (10/10) SHOWED NO SIGNS OF CONTAMINATION/APPEARANCE DEFECTS, FILL VOLUME DEFECTS, OR CRACKED TUBE DEFECTS. HOWEVER, THERE WERE 7/10 RETENTION SAMPLES THAT HAD CROOKED CAPS. FOR FURTHER INVESTIGATION OF CONTAMINATION TWO UNINOCULATED TUBES WERE INCUBATED. ONE TUBE WAS PLACED INTO 20-25-DEGREE C INCUBATION AND ONE TUBE WAS PLACED IN 33-37- DEGREE C INCUBATION AND AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES.BATCH 1354776.THE BATCH HISTORY RECORD REVIEW FOR BATCH 1354776 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING 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. 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 THIS BATCH FOR ANY DEFECT. RETENTION SAMPLES FROM BATCH 1354776 (10 TUBES) WERE AVAILABLE FOR INVESTIGATION. EACH RETENTION TUBE (10/10) SHOWED NO SIGNS OF CONTAMINATION/APPEARANCE, FILL VOLUME DEFECTS, OR CRACKED TUBE DEFECTS. 10/10 RETENTION SAMPLES DID HAVE CROOKED CAPS. FOR FURTHER INVESTIGATION OF CONTAMINATION, TWO UNINOCULATED TUBES WERE INCUBATED. ONE TUBE WAS PLACED INTO 20-25-DEGREE C INCUBATION AND ONE TUBE WAS PLACED IN 33-37- DEGREE C INCUBATION AND AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES.UNKNOWN BATCH CUSTOMER DID NOT PROVIDE A BATCH NUMBER OR RETURNS FOR THIS COMPLAINT INVESTIGATION. RETENTION SAMPLES COULD NOT BE INVESTIGATED DUE TO THE BATCH NUMBER BEING UNKNOWN. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR TSB 15ML (MATERIAL 221823) AND NO QUALITY NOTIFICATION TRENDS HAVE BEEN IDENTIFIED FOR THIS MATERIAL FOR EMPTY CONTAINERS IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221823 AND THERE ARE NO TRENDS FOR EMPTY CONTAINER IN THE LAST 12 MONTHS. SIX PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A PARTIAL CARTON. FOUR TUBES FROM BATCH 2019003 CAN BE OBSERVED. THERE IS BROKEN GLASS ALONG THE OPENING FLAP OF THE CARTON. THE SECOND PHOTO SHOWS AN OPEN PARTIAL CARTON AND A 100-PACK TUBE RACK FROM BATCH 2019003. ONE TUBE IS BROKEN. THERE IS A MISSING TUBE SPOT IN THE CORNER OF THE TUBE RACK. THERE IS BROKEN GLASS ALONG THE OPENING FLAP OF THE CARTON. THERE ALSO IS BROKEN GLASS IN THE MISSING TUBE SPOT AND A BROKEN TUBE IS ON THE TUBE RACK. THE THIRD PHOTO SHOWS SIX TUBES FROM BATCH 2019003. TWO TUBES DO APPEAR TO BE CONTAMINATED. ONE TUBE APPEARS TO BE TURBID. THREE TUBES HAVE AN EXPECTED APPEARANCE. THE FOURTH PHOTO SHOWS THREE PARTIAL TUBES FROM BATCH 2019003. THE CAPS CANNOT BE OBSERVED FROM THE PHOTO. THE MEDIA APPEARS TO BE CLEAR MEDIUM YELLOW AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS. THERE DOES APPEAR TO BE SCRATCHES OR SMUDGES ON THE TUBES. THE FIFTH PHOTO SHOWS FIVE BROKEN TUBES. TWO BROKEN TUBES ARE FROM BATCH 1354776 AND THREE BROKEN TUBES ARE FROM BATCH 2019003. THE LAST PHOTO SHOWS THREE PARTIAL TUBES FROM BATCH 1354776. ONE TUBE WAS USED TO COMPARE THE EXPECTED FILL VOLUME. THE TUBE ON THE LEFT SHOWS FILL THAT IS THE EXPECTED FILL. THE MIDDLE TUBE AND TUBE ON THE RIGHT SHOW FILL THAT IS LESS THAN THE EXPECTED FILL. THE CAPS ON ALL THREE TUBES DO APPEAR TO BE SLIGHTLY CROOKED. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CROOKED CAPS BASED ON THE RETENTION SAMPLE INVESTIGATION FOR BATCH 2019003. THE COMPLAINT CAN BE CONFIRMED FOR CROOKED CAPS FOR BATCH 1354776 BASED ON THE OBSERVATIONS IN THE RETENTION SAMPLES AND EVIDENCE PROVIDED BY THE PHOTOS. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION FOR BATCH 2019003 BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. THIS COMPLAINT CANNOT BE CONFIRMED FOR A COSMETIC MEDIA DRIP FOR BATCH 2019003 OR BATCH 1354776 BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS PROVIDED. THIS COMPLAINT CAN BE CONFIRMED FOR BROKEN TUBES BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS FOR BATCH 2019003 AND BATCH 1354776. THIS COMPLAINT CANNOT BE CONFIRMED FOR A FILL VOLUME DEFECT FOR BATCH 2019003. THE COMPLAINT CAN BE CONFIRMED FOR A FILL VOLUME DEFECT FOR BATCH 1354776 BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS. THE COMPLAINT CANNOT BE CONFIRMED FOR AN EMPTY CONTAINER BASED ON MATERIAL TRENDING FOR MATERIAL 221823 AND DUE TO THE BATCH NUMBER BEING UNKNOWN. BD WILL CONTINUE TO TREND COMPLAINTS FOR FILL VOLUME, CONTAMINATION, COSMETIC/APPEARANCE, CROOKED CAPS, BROKEN/CRACKED TUBES, AND EMPTY TUBES. NO ADDITIONAL ACTIONS ARE INDICATED AT THIS TIME.IT IS TO BE NOTED THAT BD SHIPS PRODUCT IN TEMPERATURE CONTROLLED TRUCKS TO DISTRIBUTION CENTERS. DISTRIBUTION CENTERS ARE PROVIDED WITH SHIPPING AND STORAGE GUIDELINES. MISHANDLING OF THE PRODUCT AND VIBRATIONS DURING SHIPPING CAN CAUSE BROKEN TUBES.
IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: BACTERIAL GROWTH: 5 TUBES.
IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF BIOLOGICAL CONTAMINATION.THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER:BACTERIAL GROWTH: 5 TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173792 | BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221823 | 2019003 | 30382902218235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |