MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING

Catalog Number 245124

Device Problem Microbial Contamination of Device (2303)

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

Event Date 04/02/2024

Event Type  malfunction  

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.

Event Description

It was reported before using the bd bactec¿ mgit¿ 960 supplement kit there was a fungus growing in the media.There was no report of impact to the patient or user.

Event Description

It was reported before using the bd bactec¿ mgit¿ 960 supplement kit there was a fungus growing in the media.There was no report of impact to the patient or user.

Manufacturer Narrative

The following fields were updated due to additional information in mfr report # 1119779-2024-00324: d4.Medical device lot #: 3194852.D4.Medical device expiration date: 01/05/2025.H4.Device manufacture date: 07/13/2023.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
• 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: 19200836
• MDR Text Key: 341401468
• Report Number: 1119779-2024-00324
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451242
• UDI-Public: (01)00382902451242
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/09/2024

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: 245124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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