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

Model Number 441385

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 03/13/2022

Event Type  malfunction  

Manufacturer Narrative

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 a bottle broke and leaked inside the bd bactec¿ fx, instrument top, packaged instrument.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "a bottle broke in drawer b station c4, some of the bottle is still stuck in the station.".

Event Description

It was reported that a bottle broke and leaked inside the bd bactec¿ fx, instrument top, packaged instrument.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "a bottle broke in drawer b station c4, some of the bottle is still stuck in the station.".

Manufacturer Narrative

H.6 investigation summary: the complaint alleges broken bottle issue were observed on the (instrument bactec fx catalog number 441385, serial number (b)(6).The bd field service engineer was dispatched and removed the broken bottle and later performed cleaning the rack with disinfectant.The fse performed testing, thus resolving the issue and the instrument is working properly.This is the unconfirmed complaint of the bd product and the root cause is unable to be determined with the provided information.No parts were replaced as part of the complaint and no samples were returned and thus returned sample analysis cannot be performed.Review of device history record for instrument is not required because this complaint does not allege an early life failure or failure at installation.Service history review was performed for the instrument and there were no additional work order related to this failure mode.No new or modified risks have been identified.Bd quality will continue to monitor for trends associated with this complaint.

• 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: 14087807
• MDR Text Key: 298656286
• Report Number: 1119779-2022-00552
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• 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

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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