MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. UNSPECIFIED BD BACTEC ANAEROBIC CULTURE VIAL (GLASS); 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	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.D4.Unique identifier (udi) #: unknown.E.1.Initial reporter phone #: (b)(6).H4.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using an unspecified bd bactec anaerobic culture vial (glass) one bottle broke inside the instrument, causing blood/sample to leak out.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: d4.Medical device catalog #: 442265, d4.Medical device lot#: 4312345, d4.Medical device expiration date: 13-aug-2028, d4.Unique identifier (udi) #: (b)(4), h4.Device manufacture date: 18-nov-2024.Investigation summary: catalog 442265, batch no.4312345.Customer reported a broken glass issue.Neither photos nor returned good samples were received.Bd was unable to reproduce customer¿s experience with the bactec product for leakage defect.Satisfactory results were obtained from retention samples when visually inspected.Batch history record review did not identify any evidence for which the customer submitted the complaint.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 in unconfirmed based on retention samples and batch history record review results.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.No correctives 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 an unspecified bd bactec anaerobic culture vial (glass) one bottle broke inside the instrument, causing blood/sample to leak out.No adverse impact was reported regarding the patient or user.

• Brand Name: UNSPECIFIED BD BACTEC ANAEROBIC CULTURE VIAL (GLASS)
• 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: 21652710
• Report Number: 2647876-2025-00025
• Device Sequence Number: 9276556
• Product Code: MDB
• UDI-Device Identifier: 00382904422653
• UDI-Public: (01)00382904422653(11)241118(17)280813(10)4312345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNKNOWN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: Health Professional
• Device Catalogue Number: 442265
• Device Lot Number: 4312345
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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