MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BACTEC PEDS PLUS; System, Blood Culturing

Catalog Number	442020
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bactec¿ peds plus¿/ f culture vials (plastic), there was one false negative result.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: introduction: material #: 442020 lot/batch/serial #: unknown customer claim: i request verification of the bactec equipment.The equipment released a sample with a negative result on (b)(6) at 5:45 pm, and hours later (7:46 pm) it reported that the same sample was positive.And when we performed the plate culture, the sample was positive.Attached is a screenshot of the audit report.Returned material analysis: epicenter reports were provided; however, the corresponding plots were not available for review.Investigational testing/ review: waters was not able to perform an investigation to the retention samples since batch number is unknown.The sensor inside the vial will not appear visibly different in positive and negative vials, however, the bd bactec¿ fluorescent series instrument can determine a difference in fluorescence.If at the end of the testing period a negative vial appears visually positive (i.E., chocolatized blood, bulging septum, and/or lysed), it should be subcultured and gram stained and treated as a presumptively positive.For maximum yield of isolates, negative cultures may be checked by stain and/or subcultured prior to discarding as negative.False negative readings may result when certain organisms are present which do not produce enough co2 to be detected by the system or significant growth has occurred before placing the vial into the system.Conclusion/outcome: based on the available information, the complaint could not be confirmed.The batch/lot number was not provided; therefore, retention sample testing, lot-specific complaint history review, and batch history record review could not be performed.No objective evidence was available to support a product-related failure.Consequently, no corrective actions were required.A cross-functional team continues to monitor product complaints for trends and determines whether additional actions are warranted.

• Brand Name: BACTEC PEDS PLUS
• 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 ; +1(410)316-4000
• MDR Report Key: 50303791
• Report Number: 2647876-2026-00091
• Device Sequence Number: 18799090
• Product Code: MDB
• UDI-Device Identifier: 30382904420209
• UDI-Public: (01)30382904420209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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 Catalogue Number: 442020
• Device Lot Number: unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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