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

Model Number	442296
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use with the bd bactec¿ fx40 instrument, false positive results were obtained.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: two cases of false positive result.
Event or Problem Description
It was reported that during use with the bd bactec¿ fx40 instrument, false positive results were obtained.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: two cases of false positive result.
Additional Manufacturer Narrative
H.6 investigation summary: a failure was reported on a bd bactec fx40 (p/n 442296, s/n (b)(6) ).A field service engineer (fse) was dispatched.The fse performed the recommended inspection of the instrument, no problems were found with the instrument.The root cause was unable to be determined.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.Complaints for results issues are within statistical control for the month of april 2022.The upper control limit was not breached.Quality will continue to monitor the results issues complaints for bactec fx40 products.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.Per baltrmbactecinstraph rev 15 the potential risk of the reported failure mode is user inconvenience , which is an s1; reference row id 1.6a.H3 other text : see h.10.

• 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: 14526390
• Report Number: 1119779-2022-00777
• Device Sequence Number: 5836404
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 00382904422967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/03/2022

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: 442296
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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