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

Model Number 441385

Device Problem False Positive Result (1227)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while testing with the bd bactec¿ fx, instrument top, packaged, the instrument produced false positive results.Confirmatory gram and subculture testing was performed and the result was negative.Erroneous results were not reported and there was no patient impact.The following information was provided by the initial reporter: false positives.

Manufacturer Narrative

H.6.Investigation: customer reported an issue on a bd bactec fx top instrument (p/n 441385, (b)(6) ).Customer indicated about the false positives.No erroneous results were reported to doctors, and patients were not impacted.The field service engineer (fse) was dispatched and discovered the that the false positives are caused due to worn blower coupling.The fse replaced the rack (#pn (b)(4) ).The instrument is deemed functional and handed over to the customer for use.This is a confirmed failure of the bd product.Review of device history record for this instrument not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Device was installed on 7/13/2015.Service history review was performed for this instrument and no additional work orders were observed for the complaint failure mode reported.Samples were not received by quality for investigation.If samples are received at a later date, the complaint may be reopened.The root cause was worn blower couplings.Capa#2660061 was recently implemented for false positives.Bd quality will continue to closely monitor for trends associated with this failure.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.H3 other text : see h.10.

Event Description

It was reported while testing with the bd bactec¿ fx, instrument top, packaged, the instrument produced false positive results.Confirmatory gram and subculture testing was performed and the result was negative.Erroneous results were not reported and there was no patient impact.The following information was provided by the initial reporter: false positives.

• 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: 13005807
• MDR Text Key: 285009389
• Report Number: 1119779-2021-01964
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• 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