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

Model Number	442296
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.Initial reporter phone number:(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 by the customer that there was false negative on bd bactec¿ fx40 instrument.Gram stain was performed to confirm.No patient impact was reported there was one occurrence in this event with no patient impact.The following information was provided by the customer: the customer wishes to understand a curve for a bottle: a bactec bottle (n° 449278015834) was sent pos to the sil but the bactec appears as neg on the curve report.Its curve is clearly a pos curve.The client informs me that they did a subculture and gram stain which showed the presence of bacteria.
Event or Problem Description
It was reported by the customer that there was false negative on bd bactec¿ fx40 instrument.Gram stain was performed to confirm.No patient impact was reported there was one occurrence in this event with no patient impact.The following information was provided by the customer: "the customer wishes to understand a curve for a bottle: a bactec bottle (n° 449278015834) was sent pos to the sil but the bactec appears as neg on the curve report.Its curve is clearly a pos curve.The client informs me that they did a subculture and gram stain which showed the presence of bacteria.".
Additional Manufacturer Narrative
H.6 investigation summary: a failure was reported on a bd bactec fx40 (p/n 442296, s/n (b)(6)).Customer reported a false negative issue on their instrument.Bd remote assistance worked with the customer.It was discovered that this sample was reinserted into the instrument after going through testing in the instrument for 3 days.This reinsertion of the instrument caused the false negative.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 result issues.Complaints for instrument performance / operation issues are within statistical control for the month of august 2022.The upper control limit was not breached.Quality will continue to monitor the instrument performance / operation 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 patient not treated appropriately then has permanent impairment and/or severe symptoms, which is an s4.

• 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: 15415441
• Report Number: 1119779-2022-01186
• Device Sequence Number: 19488203
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 00382904422967
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 08/30/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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