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

Catalog Number 441386

Device Problem Leak/Splash (1354)

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

Event Date 03/24/2024

Event Type  malfunction  

Event Description

It was reported that while using the bd bactec¿ fx, instrument bottom, packaged the customer indicated a broken vial was in the instrument.The customer was cautioned to use ppe when removing the vial, and there was no report of patient impact.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary a complaint of "broken bottle" was received against instrument bottom bactec fx packaged material number: 441386, serial number: (b)(6).A bd field service engineer (fse) was dispatched.The fse was cleaned the station and temporarily blocked the station, thus the issue was resolved.Instrument was found to be functional and released to customer for regular operation.This is an unconfirmed complaint, and the root cause was unable to be determined.Device history record review for the instrument (b)(6) , is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review revealed no previous complaints for this issue.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.

Event Description

It was reported that while using the bd bactec¿ fx, instrument bottom, packaged the customer indicated a broken vial was in the instrument.The customer was cautioned to use ppe when removing the vial, and there was no report of patient impact.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19169931
• MDR Text Key: 341356728
• Report Number: 1119779-2024-00314
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: (01)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: 04/29/2024

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 Catalogue Number: 441386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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