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

Model Number	441386
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd bactec¿ fx, instrument top, packaged device, a false negative result was obtained.There was no report of confirmatory test.There were no results reported to physicians and there was no patient impact.The following information was provided by the initial reporter: "false negative".
Additional Manufacturer Narrative
Initial reporter address: (b)(6).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 that while using the bd bactec¿ fx, instrument top, packaged device, a false negative result was obtained.There was no report of confirmatory test.There were no results reported to physicians and there was no patient impact.The following information was provided by the initial reporter: "false negative.".
Additional Manufacturer Narrative
H.6 investigation summary: bd field service engineering went onsite to investigate the issue and confirmed the failures.The engineer noted of contact issues with the rack and reseated racks ensuring the connection and reset the system.This is a confirmed complaint.Device history review is not required as this failure does not allege an early life failure or failure at install.Sample analysis is not required as no samples were returned for analysis.If samples are received at a later date, the complaint may be reopened.Service history review showed no previous complaints related to this failure.The root cause is connection issues.Bd currently has a capa 4777860 open to address connection issues with the vial storage rack.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Complaints for results are under statistical control for the month of june 2022.The upper control limit was not breached, and no trends have been identified.Review of risk management documentation indicates the potential risk of the reported failure mode was assessed as severity s1 via document baltrmbactecinstraph rev 15, row id 1.2a h3 other text : see h.10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15019744
• Report Number: 1119779-2022-00992
• Device Sequence Number: 6743957
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 10/31/2022

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 Model Number: 441386
• Device Catalogue Number: 441386
• 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: 06/21/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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