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

Model Number 441385

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 07/28/2021

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 when using the instrument top bactec fx packaged, the device experienced a broken bottle.The following information was provided by the initial reporter.The customer stated: customer has been guided trough the cleaning procedure for leaking vial.The customer notifies that an anaerobic sample inserted on 28/06 has leaked only today with negative tag access number 0209241101 bottle number 449267.

Manufacturer Narrative

H.6.Investigation: a failure was reported on a bd bactec fx top instrument (p/n 441385, s/n (b)(6) ).Customer indicated that the anaerobic sample inserted has leaked after a month.The bd remote assistance communicated with the customer and confirmed that the issue was caused due to the customer operational problem.This is an unconfirmed failure of a bd product as this is customer workflow induce.Review of device history record for instrument serial number, ft4915is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on 12/17/2015.Service history review was performed for the instrument ft4915 and no additional work orders were observed for the complaint failure mode reported.No parts or materials were returned or replaced as a part of this complaint.The root cause was customer workflow induce.Bd quality will continue to closely monitor for trends associated with this complaint.H3 other text : see h.10.

Event Description

It was reported when using the instrument top bactec fx packaged, the device experienced a broken bottle.The following information was provided by the initial reporter.The customer stated: customer has been guided trough the cleaning procedure for leaking vial.The customer notifies that an anaerobic sample inserted on 28/06 has leaked only today with negative tag access number 0209241101 bottle number 449267.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12565842
• MDR Text Key: 274491946
• Report Number: 1119779-2021-01602
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• 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