MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 320 SYSTEM; SYSTEM, BLOOD CULTURING

Catalog Number 441743

Device Problem False Negative Result (1225)

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

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device expiration date: unknown h6.Investigation exec summary catalog # 441743, s/n (b)(6) : the customer reported the instrument reported a false negative result a year ago.No patient impact was reported.It was reported that there is no problem with the instrument.The root cause of this complaint was not determined.This complaint is not being confirmed as no instrument malfunction was identified.Review of the device history record for instrument s/n (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the instrument has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no recent additional work orders were observed for the complaint failure mode reported.No samples or parts were expected to be returned for this complaint, therefore, a returned sample analysis is not required.Bd quality will continue to closely monitor for trends associated with results related complaints.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

Event Description

It was reported that while using bd bactec¿ mgit¿ 320 system a false negative result was found.No patient impact reported.

• Brand Name: BD BACTEC¿ MGIT¿ 320 SYSTEM
• 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: 19181913
• MDR Text Key: 341693040
• Report Number: 1119779-2024-00316
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974883
• 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
• Report Date: 04/01/2024

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: 441743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2018
• 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