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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: catalog 442022.Batch no.5169301.Customer reported a damage cap and leakage defect.Photos with the damage were received.Bd was unable to reproduce customer¿s experience with the bactec product.Satisfactory results were obtained from retention samples when visually inspected for damage cap and leakage.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.In addition, five (5) samples were randomly selected and inspected for cap seal integrity with satisfactory results.Vacuum draw test was performed with satisfactory results.Complaint is confirmed based on photos received.The leakage occurred due to the damage of the cap.No trend has been identified for reported defect.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of damage, contamination, or deterioration.Vials displaying evidence of damage or contamination such as leakage, cloudiness, discoloration (darkening), bulging or depressed septum should not be used.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 investigation process.
Event or Problem Description
It was reported while using bd bactec¿ plus anaerobic/f culture vials (plastic) blood leaked from one bottle.No adverse impact was reported regarding the patient or user at this time.
Additional Manufacturer Narrative
E.1: initial reporter facility name: (b)(6) hospital.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 anaerobic/f culture vials (plastic) blood leaked from one bottle.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: 23818811
• Report Number: 2647876-2025-00755
• Device Sequence Number: 13089716
• Product Code: MDB
• UDI-Device Identifier: 30382904420223
• UDI-Public: (01)30382904420223(17)260323(10)5169301
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 03/23/2026
• Device Catalogue Number: 442022
• Device Lot Number: 5169301
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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