MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX40 INSTRUMENT; SYSTEM, BLOOD CULTURING

Catalog Number	442296
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.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 during use the bd bactec¿ fx40 instrument poor growth curves were observed, which resulted in false negatives.This is a report of a single occurrence.No false results were reported out to the clinician or the patient.False results were due to user error.The following information was provided by the initial reporter: problems with growth curve - growth stops.Recommendations to the client were provided wo-02344592.Recommendations were given for the inoculated vials to be introduced into the equipment during the two hours following the sampling, since the false negatives occurred because the vials were entered more than 6 hours after the sample had been taken,problem was user error that was solved after this recommendations.
Additional Manufacturer Narrative
H6: investigation summary: a failure was reported on a bd bactec fx40 (p/n 442296, s/n (b)(6)).Customer reported results issues on their instrument.Bd remote assistance worked with the customer and found that there was an error in sample handling.The samples were collected more than six hours before entering the vials into the instrument.The root cause was a customer workflow issue.This is an unconfirmed failure of a bd product.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.This complaint is not an early life failure (elf) of the device.Since the installation of this instrument, there have been service events, including pms (preventative maintenance) which have altered the instrument from its original state.Therefore, review of the device history record (dhr) from manufacturing is not applicable.Service history review for this instrument was completed and revealed no previous complaints related to results issues.
Event or Problem Description
It was reported that during use the bd bactec¿ fx40 instrument poor growth curves were observed, which resulted in false negatives.This is a report of a single occurrence.No false results were reported out to the clinician or the patient.False results were due to user error.The following information was provided by the initial reporter: problems with growth curve - growth stops.Recommendations to the client were provided (b)(4).Recommendations were given for the inoculated vials to be introduced into the equipment during the two hours following the sampling, since the false negatives occurred because the vials were entered more than 6 hours after the sample had been taken,problem was user error that was solved after this recommendations.

• Brand Name: BD BACTEC¿ FX40 INSTRUMENT
• 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: 14862303
• Report Number: 1119779-2022-00944
• Device Sequence Number: 5073929
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 382904422967
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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 Catalogue Number: 442296
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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