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

Model Number 441386

Device Problem False Positive Result (1227)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ fx, instrument bottom, packaged false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: call activity comment: customer problem: (b)(4)/ false positive and vial presence switch error.

Manufacturer Narrative

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

Manufacturer Narrative

H.6.Investigation: customer reported an issue on a bd bactec fx bottom instrument (p/n 441386, s/n (b)(6)).Customer indicated about the false positives and vial presence switch error.No erroneous results were reported to doctors, and patients were not impacted.Bd service communicated with the customer and discovered that the issue was due to defective bottle.Bd service confirmed that the issue is not related to the instrument.This is an unconfirmed failure of the bd product.Review of device history record for this instrument is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.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 unable to be determined.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.

Event Description

It was reported that while using bd bactec¿ fx, instrument bottom, packaged false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "call activity comment: customer problem: fx441386 / false positive and vial presence switch error".

• Brand Name: BD BACTEC¿ FX, INSTRUMENT BOTTOM, 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: 13114504
• MDR Text Key: 286442669
• Report Number: 1119779-2021-02063
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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
• Device Operator: Other
• Device Model Number: 441386
• Device Catalogue Number: 441386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1