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

Catalog Number	442022
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
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 addr 1: (b)(6).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
One (1) false negative result for acinetobacter baumannii was reported after the use of expired bd bactec¿ plus anaerobic/f culture vials (plastic).The issue was attributed to user error.No adverse impact was reported regarding the patient or user at this time.
Additional Manufacturer Narrative
Investigation summary: introduction: material #: 442022 lot/batch/serial #: (b)(6) (expiration date: 10apr2026) customer claim: we have 1 false positive result and 2 false negative results from the blood culture bottles for anaerobes with lot 5155532 with an expiration date of october 3, 2026.Investigational testing/ review: upon further evaluation it was noticed that complaint received was from a product that had already expired.Product insert warnings and precautions sections state 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.Do not use culture vials past their expiration date.Users are cautioned in the package insert under limitation of the procedure: a gram-stained smear from a culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.In addition, the patient specimen may contain organisms that will not grow in the culture medium or in media used for subculture.Such specimens should be subculture to special media as appropriate.Complaint history review: 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.Conclusion/outcome: complaint is unconfirmed.No corrective actions were required.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The waters business team regularly reviews the collected data for identification of emerging trends monthly.
Event or Problem Description
One (1) false negative result for acinetobacter baumannii was reported after the use of expired bd bactec¿ plus anaerobic/f culture vials (plastic).The issue was attributed to user error.No adverse impact was reported regarding the patient or user at this time.

• Brand Name: BD BACTEC¿ PLUS ANAEROBIC/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: 25034194
• Report Number: 2647876-2026-00034
• Device Sequence Number: 9039515
• Product Code: MDB
• UDI-Device Identifier: 30382904420223
• UDI-Public: (01)30382904420223(17)260310(10)5155332
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 03/10/2026
• Device Catalogue Number: 442022
• Device Lot Number: 5155332
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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