MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS; SYSTEM, BLOOD CULTURING

Catalog Number	442288
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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)#: k970512.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¿ myco/f lytic culture vials there was one false negative result.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: catalog 442288.Batch no.5057481.Customer reported a false negative result.Photo of a bottle without sensor was received.Bd was unable to reproduce customer¿s experience with bactec product.Satisfactory results were obtained from retention samples when tested for microbial instrument detection as per quality procedures.Batch history record review did not identify any evidence for which the customer submitted the complaint (i.E.False negative).Microbial instrument detection indicated that the product is performing as expected.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 based on photo received of a bottle without the sensor.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.The specimen must be collected using sterile techniques to reduce the chance of contamination.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
It was reported while using bd bactec¿ myco/f lytic culture vials there was one false negative result.No adverse impact was reported regarding the patient or user.

• Brand Name: BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
• 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: 23465559
• Report Number: 2647876-2025-00658
• Device Sequence Number: 8870649
• Product Code: MDB
• UDI-Device Identifier: 00382904422882
• UDI-Public: (01)00382904422882(17)251202(10)5057481
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 12/02/2025
• Device Catalogue Number: 442288
• Device Lot Number: 5057481
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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