BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
Report
- Report Number
- 1119779-2024-00298
- Event Type
- Malfunction
- Date Received
- April 17, 2024
- Date of Event
- March 27, 2024
- Report Date
- September 9, 2024
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 30382902451229
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 BATCHES 3011178 AND 3145748 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES AND CHECKS FOR TORQUE CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND OTHER COMPLAINTS HAVE BEEN MADE ON BATCH 3011178 AND 3145748 FOR LEAKING AND NO OTHER COMPLAINTS WERE TAKEN ON BATCH 3145748 FOR MISSING LABELS. RETENTION SAMPLES (100 PER BATCH) WERE AVAILABLE FOR INSPECTION. THERE WERE NO MISSING LABEL DEFECTS, LOW FILLS, OR LEAKING OBSERVED IN THE RETENTION SAMPLES. ONE PHOTO AND A COLLAGE OF THREE PHOTOS WERE SUBMITTED TO REVIEW FOR THIS COMPLAINT. THE FIRST PHOTO SHOWS A TUBE TRAY WITH FIVE TUBES. THE TWO TUBES WITH BATCH INFORMATION ARE FROM BATCH 3145748 WITH EXPIRATION 2024-11-24. THE THIRD AND FOURTH TUBES FROM THE LEFT ARE MISSING LABELS. THE TUBE THIRD FROM THE RIGHT ALSO HAS A LOW FILL. THE OTHER FOUR TUBES CANNOT BE ASSESSED FOR FILL VOLUME USING THIS PHOTO. THE PHOTO COLLAGE CONTAINS THREE ADDITIONAL PHOTOS. THE FIRST PHOTO IN THE COLLAGE SHOWS TWO TUBES. THE TUBE ON THE LEFT IS MISSING A LABEL AND THE TUBE ON THE RIGHT IS FROM BATCH 3145748 AND HAS A LOW FILL. THE SECOND PHOTO IN THE COLLAGE IS A TUBE FROM BATCH 3011178 WITH EXPIRATION 2024-07-07. THE TUBE APPEARS TO HAVE A LOW FILL. WHILE LEAKING CANNOT BE ASSESSED IN THE IMAGE, THE LOW FILL IS INDICATIVE OF LEAKING. THE FINAL PHOTO IN THE COLLAGE IS A TUBE FROM BATCH 3145748 WITH EXPIRATION 2024-11-24. THE TUBE IN THIS IMAGE IS EMPTY. NO RETURNS WERE RECEIVED TO ASSIST IN THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED FOR MISSING LABELS, LOW FILL, AND LOOSE CAP. NO TREND IDENTIFIED. BD WILL CONTINUE TO TREND COMPLAINTS.
E.1. INITIAL REPORTER FACILITY NAME: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED PRIOR TO USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THE PRODUCT LABEL WAS MISSING ON TWO (2) TUBES. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
IT WAS REPORTED PRIOR TO USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THE PRODUCT LABEL WAS MISSING ON TWO (2) TUBES. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1023799 | BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. (SPARKS) | 3145748 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |