MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number	442023
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Report 1: it was reported while using bd bactec¿ plus aerobic/f culture vials (plastic), there was biological contamination seen in one sample identified as bacillus cereus.No adverse impact was reported regarding the patient or user at this time.
Additional Manufacturer Narrative
Investigation summary: catalog 442023.Batch no.5218046.Customer reported a contamination issue.Photo of an inoculated bottle with a cap seal issue was received.Waters was unable to reproduce customer¿s experience with the bactec product for contamination issue.Satisfactory results were obtained from retention samples when visually inspected.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.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.Complaint is confirmed for cap seal defect-based photos received.A technical assessment was conducted to determine whether the optima capper machine and the cap vision system experienced any mechanical issues or breakdowns on the manufacturing date of the referenced batch.Review of breakdown and incident reports confirmed that no problems related to this issue were reported on that date.The investigation also, verified that preventive maintenance for both the optima capper machine and the cap vision system was completed on schedule.However, evaluation of production reports indicated cap-related issues.These types of events are fixed during the manufacturing process.Prior to each lot¿s manufacturing process, the capper sealing and spinning sections are evaluated, and technicians perform cap seal verification.Product insert states prior to use; the user should examine the vials for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.On rare occasions, a vial may not be sealed sufficiently.The contents of the vials may leak or spill, especially if the vial is inverted.If the vial has been inoculated, treat the leak or spill with caution, as pathogenic organisms/agents may be present.Before discarding, sterilize all inoculated vials by autoclaving.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
Event or Problem Description
Report 1: it was reported while using bd bactec¿ plus aerobic/f culture vials (plastic), there was biological contamination seen in one sample identified as bacillus cereus.No adverse impact was reported regarding the patient or user at this time.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24390997
• Report Number: 2647876-2026-00014
• Device Sequence Number: 18767866
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239(17)260512(10)5218046
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/12/2026
• Device Catalogue Number: 442023
• Device Lot Number: 5218046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown