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

Catalog Number 441385

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.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.

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged miss association was observed 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: "software or equipment itself that could have hypothesized the probability of a false positive result given at some point by the operation or reading of the bd bactectm fx positivity and negativity algorithms during monitoring of the sample incubation.".

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged misassociation was observed 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: "software or equipment itself that could have hypothesized the probability of a false positive result given at some point by the operation or reading of the bd bactectm fx positivity and negativity algorithms during monitoring of the sample incubation.".

Manufacturer Narrative

This mdr should be considered cancelled.This customer does not use the bactec assays with patient samples for diagnostic propose.

• 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: 13120560
• MDR Text Key: 288502009
• Report Number: 1119779-2021-02065
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 0382904413859
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K915796A
• 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: 01/04/2022

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 Catalogue Number: 441385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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