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

Model Number 441386

Device Problem Unintended Movement (3026)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 bd bactec¿ fx, instrument top, packaged right front leveling foot dislodged from strut.The following information was provided by the initial reporter: front right leveling foot broken off of strut.No injuries were reported.

Manufacturer Narrative

H.6 investigation summary: customer contacted bd support regarding their bactec fx bottom 441386 sn fb1414 alleging the leveling foot had broken.A bd field service engineer went onsite to investigate and confirmed the issue.The fse replaced the foot and ensured the instrument was functioning properly before turning back over to the customer.This is a confirmed complaint.Dhr review is not required as this complaint has been confirmed as a failure of the bd product through other elements as noted in the investigation.Service history review shows no prior complaints have been opened related to this failure mode.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.The root cause is unknown.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 that bd bactec¿ fx, instrument top, packaged right front leveling foot dislodged from strut.The following information was provided by the initial reporter: front right leveling foot broken off of strut.No injuries were reported.

• 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: 16056776
• MDR Text Key: 306837014
• Report Number: 1119779-2022-01548
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/15/2023

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: 12/15/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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