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

Model Number 441385

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using the bd bactec¿ fx, instrument top, packaged there was a false negative blood culture bottle.A patient sample was involved but there was no report of clinical signs, symptoms, conditions, health consequences or impact reported.The following information was provided by the initial reporter: customer reports a false negative blood culture bottle.This must be checked by the technical side in order to be able to rule out a device defect.

Event Description

It was reported that while using the bd bactec¿ fx, instrument top, packaged there was a false negative blood culture bottle.A patient sample was involved but there was no report of clinical signs, symptoms, conditions, health consequences or impact reported.The following information was provided by the initial reporter: customer reports a false negative blood culture bottle.This must be checked by the technical side in order to be able to rule out a device defect.

Manufacturer Narrative

Investigation summary: service investigated the issue and reviewed log files for analysis, and found the customer was using a sample from an abscess which is considered an off-label specimen and are not an approved sample type.Furthermore, the log files showed no issues occurring with the functionality of the instrument.The case data notes further review showing the reagent used was expired.This is an unconfirmed complaint.Device history review is not required as this does not allege an early life failure or failure at install.Service history review showed no prior complaints related to this failure mode.Sample review in the form of log files showed no issues with the instrument.The root cause is due to expired reagent and off-label sample use.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 september 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 2.6.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED
• Type of Device: 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: 15443573
• MDR Text Key: 300459692
• Report Number: 1119779-2022-01198
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 441385
• Device Catalogue Number: 441385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1