BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2025-00754
- Event Type
- Malfunction
- Date Received
- November 13, 2025
- Date of Event
- October 30, 2025
- Report Date
- February 4, 2026
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: CATALOG 442023; BATCH NO. 5093570. THE CUSTOMER REPORTED A MISSING VIAL LABEL AND A DOUBLE LABEL DEFECT. A PHOTO DOCUMENTING THE ISSUE WAS RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR REPORTED DEFECT (NO VIAL LABEL AND DOUBLE LABEL). BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE AS REPORTED DEFECT CODE. A TECHNICAL ASSESSMENT WAS CONDUCTED TO DETERMINE WHETHER THE WEILER BOTTLE LABELER PACKAGING EQUIPMENT EXPERIENCED ANY MECHANICAL ISSUES OR BREAKDOWNS DURING THE LABELING PROCESS FOR THE AFOREMENTIONED BATCH. PREVENTIVE MAINTENANCE ACTIVITIES FOR THE WEILER BOTTLE LABELER WERE COMPLETED ON SCHEDULE. A REVIEW OF BREAKDOWN AND INCIDENT REPORTS CONFIRMED THAT NO ISSUES OR MALFUNCTIONS RELATED TO LABEL PLACEMENT WERE IDENTIFIED. PRODUCTION DOWNTIME RECORDS INDICATED OCCASIONAL JAMS AND SYNCHRONIZATION EVENTS ON THE WEILER LABELER; HOWEVER, THESE WERE RESOLVED DURING ROUTINE OPERATION. AS PART OF LABELING PROCESS IMPROVEMENTS, THE WEILER LABELER WAS REMOVED AND REPLACED WITH A NEW SHIBUYA LABELER. THIS UPGRADE IMPROVED LABEL APPLICATION PERFORMANCE AND ENHANCED THE VISION SYSTEM¿S CAPABILITY TO DETECT BOTH UNLABELED BOTTLES AND BOTTLES WITH DOUBLE LABELS. ADDITIONALLY, DURING THE PACKAGING PROCESS OF EACH LOT, A PROCESS CONTROL REPRESENTATIVE PERFORMS CASE INSPECTIONS TO VERIFY COMPLETENESS. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO, PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. COMPLAINT IS CONFIRMED BASED ON PHOTO RECEIVED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K222591. 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 WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT AND INCLUDED TWO LABELS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT AND INCLUDED TWO LABELS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248866 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 5093570 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |