MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Catalog Number	442265
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ lytic/10 anaerobic/f culture vials blood leaked from one bottle in the bactec fx instrument.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: catalog 442265.Batch no.4235049.Customer reported a damage bottle issue.Photo was received and damage to the cap seal was observed.Bd was unable to reproduce customer¿s experience with the bactec product.Satisfactory results were obtained from retention samples when visually inspected for damage bottles.Bactec media bottles were placed inside fx instrument station and the bottles could be seated in instrument stations.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.Batch history record review was performed, and it was found that all inspections were within acceptance limits.Vacuum draw was performed with satisfactory results.Coa of glass bottle was reviewed, and product is in compliance with applicable regulatory requirements.Complaint is confirmed based on photo.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¿ lytic/10 anaerobic/f culture vials blood leaked from one bottle in the bactec fx instrument.No adverse impact was reported regarding the patient or user.

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/F 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: 20844406
• Report Number: 2647876-2024-00171
• Device Sequence Number: 7942226
• Product Code: MDB
• UDI-Device Identifier: 00382904422653
• UDI-Public: (01)00382904422653(11)240822(17)250528(10)4235049
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K954925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 05/28/2025
• Device Catalogue Number: 442265
• Device Lot Number: 4235049
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 04/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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