BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
Report
- Report Number
- 1119779-2021-01263
- Event Type
- Malfunction
- Date Received
- August 2, 2021
- Date of Event
- July 2, 2021
- Report Date
- February 11, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 30382902451229
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY MATERIAL 245122 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 BATCH 0142001 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0142001 (100 TUBES) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES SHOWED NO MEDIA DEFECTS IN 100/100 TUBES FROM VISUAL INSPECTION. NO EVIDENCE OF CONTAMINATION WAS OBSERVED IN 100/100 RETENTION SAMPLES. THE COLOR AND CLARITY FOR THIS MATERIAL WAS IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS. FOR INVESTIGATION, A TOTAL OF TEN UNINOCULATED RETENTION TUBES WERE INCUBATED FOR SEVEN DAYS. FIVE TUBES WERE PLACED IN THE 33 TO 37 DEGREE C INCUBATOR AND FIVE TUBES WERE PLACED IN THE 20 TO 25 DEGREE C INCUBATOR. NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS SEEN IN 20/20 INCUBATED RETENTION TUBES AT SEVEN DAYS INCUBATION, AND UNDER UV LIGHT THE INCUBATED TUBES DID NOT SHOW ANY INCREASED FLUORESCENCE TO INDICATE MICROBIAL GROWTH. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE PHOTO SHOWS ONE TUBE FROM BATCH 0142001. THE TUBE DOES APPEAR CONTAMINATED AS THE COLOR OF THE MEDIA IS A REDDISH BROWN. ALSO NOTED THE FILL VOLUME IS LOWER THAN THE EXPECTED AMOUNT. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED BY THE PHOTO PROVIDED. A TREND HAS NOT BEEN IDENTIFIED, THEREFORE, THERE ARE NO ACTIONS PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. " CUSTOMER REPORTED FINDING A CONTAMINATED TUBE INSIDE THE BOX. THE TUBE WAS NOT USED. "
(B)(6). 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 WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. " CUSTOMER REPORTED FINDING A CONTAMINATED TUBE INSIDE THE BOX. THE TUBE WAS NOT USED. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1155350 | BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. (SPARKS) | 245122 | 0142001 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |