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

Model Number 441385

Device Problem Unintended Movement (3026)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

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 was reported that while using bd bactec¿ fx, instrument top, packaged a mechanical leveling foot failure was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: it was reported that fx441385 / instrument is moving.

Manufacturer Narrative

After further review mfr#: 1119779-2021-01366 has been determined to be not reportable as the complaint was a request for a seismic kit.As a result mfr#: 1119779-2021-01366 is null and void.

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged a mechanical leveling foot failure was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " it was reported that fx441385 / instrument is moving.".

• 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
• MDR Report Key: 12315744
• MDR Text Key: 267071717
• Report Number: 1119779-2021-01366
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1