MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING

Catalog Number	441385
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec¿ fx, instrument top, packaged, one (1) bactec bottle broke while it was inserted into the instrument, which caused blood to leak out.The inside of the affected drawer was disassembled and cleaned.No patient impact reported.
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 that while using bd bactec¿ fx, instrument top, packaged, one (1) bactec bottle broke while it was inserted into the instrument, which caused blood to leak out.The inside of the affected drawer was disassembled and cleaned.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary: a complaint of "the bottle broke while it was inserted, causing blood to leak out" was received against instrument top bactec fx packaged material number: 441385, serial number: (b)(6).A bd field service engineer (fse) was dispatched.The fse was disassembled and cleaned the inside of the c drawer, thus the issue was resolved.Instrument was found to be functional and released to the customer for regular operation.This is an unconfirmed complaint, and the root cause was unable to be determined.Device history record review for the instrument (b)(6), is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review revealed no previous complaints for this issue.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19799660
• Report Number: 1119779-2024-00560
• Device Sequence Number: 8379891
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 441385
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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