MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BACTEC MGIT 960 INSTRUMENT 01

Catalog Number 44587001

Device Problem Leak/Splash (1354)

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

Event Date 08/25/2023

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 that while using bactec mgit 960 instrument 01 that there was a broke/ cracked tube.The following information was provided by the initial reporter: error message e06 in drawer b.Nothing is blocking the detector assy, but the calibration tube in row b was wet.

Event Description

It was reported that while using bactec mgit 960 instrument 01 that there was a broke/ cracked tube.The following information was provided by the initial reporter: error message e06 in drawer b.Nothing is blocking the detector assy, but the calibration tube in row b was wet.

Manufacturer Narrative

H.6.Investigation summary: bd quality has reviewed the complaint, service activities, and adverse event question.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Dhr review is not required 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.Complaints received for this device and reported condition will continue to be tracked and trended.Additional investigation will be performed if an actionable level is reached.

Event Description

It was reported that while using bactec mgit 960 instrument 01 that there was a broke/ cracked tube.The following information was provided by the initial reporter: error message e06 in drawer b.Nothing is blocking the detector assy, but the calibration tube in row b was wet.

Manufacturer Narrative

After further evaluation, the previous mfr report #1119779-2023-01014 was submitted in error.There was no report of serious injury, medical intervention, or reportable device malfunction.This complaint is not mdr reportable.

• Brand Name: BACTEC MGIT 960 INSTRUMENT 01
• Type of Device: NA
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17776581
• MDR Text Key: 324039334
• Report Number: 1119779-2023-01014
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 10/13/2023

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: 44587001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/22/2023; 10/13/2023
• Supplement Dates FDA Received: 09/28/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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