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

Model Number 441386

Device Problem Unintended Movement (3026)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported that the bd bactec¿ fx, instrument bottom, packaged has been found experiencing a leveling foot issue.The following has been provided by the initial reporter: customer problem: front left leveling foot broken.

Event Description

It has been reported that the bd bactec¿ fx, instrument bottom, packaged has been found experiencing a leveling foot issue.The following has been provided by the initial reporter: customer problem: front left leveling foot broken.

Manufacturer Narrative

After additional review, this mfr report #1119779-2022-00208 was submitted in error.This is not a reportable event.This mdr should be considered canceled.

• 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: 13472458
• MDR Text Key: 288595747
• Report Number: 1119779-2022-00208
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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