BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
Report
- Report Number
- 1119779-2023-00302
- Event Type
- Malfunction
- Date Received
- March 20, 2023
- Date of Event
- March 10, 2023
- Report Date
- April 20, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 30382902451229
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 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 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 1191963 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION AND FILLING 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1191963 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO DEFECTS WERE OBSERVED IN 100/100 RETENTION SAMPLES. NO LEAKING OR LABELING DEFECTS WERE OBSERVED IN 100/100 RETENTION TUBES. ALL 100/100 RETENTION TUBES WERE MEASURED USING A FILL VOLUME MEASURING TOOL. ALL 100 TUBES MEASURED AT THE ACCEPTABLE MEDIA FILL LEVEL. ALL 100/100 RETENTION TUBES HAD PROPERLY AFFIXED, LEGIBLE LABELS, AND SCANNABLE BARCODE LABELS. THREE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: TWO PHOTOS SHOW ONE TUBE FROM BATCH 1191963. THE MEDIA FILL DOES APPEAR LOWER THAN EXPECTED POSSIBLY FROM A TUBE THAT MAY HAVE LEAKED. THE THIRD PHOTO SHOWS ONE TUBE WITHOUT A LABEL. ALSO NOTED IS A BD 100-PK CARTON IN THE BACKGROUND WITH TUBES IN THE CARTON. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED FOR BOTH DEFECTS. NO COMPLAINT TRENDS FOR THIS DEFECT HAS BEEN IDENTIFIED FOR THIS PRODUCT ;NO ACTIONS ARE INDICATED AT THIS TIME. H3 OTHER TEXT : SEE H.10.
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 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML ONE BOTTLE WAS FOUND WITH NO LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TOTAL OF 3 MYCOBACTERIUM CULTURE TUBES WERE FOUND TO HAVE QUALITY PROBLEMS 1 NO LABEL.
IT WAS REPORTED THAT BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML ONE BOTTLE WAS FOUND WITH NO LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TOTAL OF 3 MYCOBACTERIUM CULTURE TUBES WERE FOUND TO HAVE QUALITY PROBLEMS 1 NO LABEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 954292 | BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. (SPARKS) | 245122 | 1191963 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |