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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 23543436
• Report Number: 2647876-2025-00754
• Device Sequence Number: 9322807
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239(17)260102(10)5093570
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/04/2026

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: 01/02/2026
• Device Catalogue Number: 442023
• Device Lot Number: 5093570
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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