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

Model Number 441386

Device Problem Structural Problem (2506)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd bactec¿ fx, instrument bottom, packaged had the strut break off and the foot is stuck.The following information was provided by the initial reporter: it was reported that strut broken off, foot stuck.

Manufacturer Narrative

H6: investigation summary customer reported a failure on a bd bactec fx bottom instrument (p/n 441386, s/n (b)(6)).Customer indicated that leveling foot found broken.A bd field service engineer (fse) was dispatched and replaced (pn# 444095 - strut & set of feet bfx spare).The instrument is deemed functional and handed over to the customer for use.This is a confirmed failure of the bd product.Review of device history record for instrument serial number, (b)(6) is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Device installed on 3/8/2011.Service history review was performed for the instrument (b)(6) 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 broken levelling foot broken.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.H3 other text : see h10.

Event Description

It was reported that the bd bactec¿ fx, instrument bottom, packaged had the strut break off and the foot is stuck.The following information was provided by the initial reporter: it was reported that strut broken off, foot stuck.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12918249
• MDR Text Key: 286066931
• Report Number: 1119779-2021-01906
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 03/07/2022
• 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