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

Model Number 245124

Device Problem Contamination (1120)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Initial reporter address: (b)(6).

Event Description

It was reported that bd bactec¿ mgit¿ 960 supplement kit contamination occurred.The following information was provided by the initial reporter: the bd growth supplement vial has come contamination inside, we can visually see the growth in the solution (see picture).

Event Description

It was reported that bd bactec¿ mgit¿ 960 supplement kit contamination occurred.The following information was provided by the initial reporter: the bd growth supplement vial has come contamination inside, we can visually see the growth in the solution (see picture).

Manufacturer Narrative

H.6 investigation summary: mgit 960 supplement kit is composed of two components: mgit panta and mgit growth supplement.Mgit panta is manufactured by rehydrating components in usp purified water and mixed into a homogenous solution.The solution is then sterile filtered, dispensed into vials and stoppered by machine.The vials are lyophilized, and crimp caps are applied per standard operating procedures (sop).Mgit 960 growth supplement is manufactured by rehydrating the media components with usp purified water and mixed until a homogeneous solution is obtained.The solution is then sterile filtered and dispensed into vials; stoppers are manually placed in the vial opening; septum caps are manually placed on top of the stopper and then mechanically crimped per sop.Six mgit panta vials are then manually packaged with six mgit growth supplement vials to make a mgit 960 supplement kit (material 245124).Growth supplement batch number 2181218 was provided for investigation.The batch history record review for growth supplement batch 2181218 was satisfactory and no quality notifications were generated during manufacturing and inspection.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include bioburden testing.Samples are incubated at 25 degrees c and at 35 degrees c for 14 days.All bioburden testing performed on this batch was satisfactory per internal procedures.Retention samples from growth supplement batch 2181218 (10 vials) were available for inspection.Microbial growth was not observed in 10/10 retention vials from visual inspection.For investigation of this complaint, retention samples were tested.Two retention growth supplement vials were incubated at 20 to 25 degrees c (1 vial) and 33 to 37 degrees c (1 vial).No microbial growth was observed in 2/2 retention vials at 14 days incubation.One photo was received to assist with the investigation.The photo shows one uncrimped growth supplement vial from batch 2181218 with what appears to be fungal growth in the media.No returns were received to assist with the investigation.No 245124 kit batch number was provided to properly complete an investigation.However, manufacturing records for growth supplement batch 2181218 were reviewed and a probable kit batch number was identified.A complaint trend was identified for contamination involving component growth supplement batch 2181218.The component was packaged into a kit that was known to be distributed in asia.Investigation of the trend found an intervention during filling of a component that required operator intervention.The intervention was for a mechanical issue that has been improved since production of this batch.Bd expects the need for interventions during the filling process for this product to be reduced going forward.Any operator interventions during manufacturing have the potential to introduce contaminants despite engineered processes and precautions.While an intervention was identified and has been improved upon, an exact root cause for the contamination could not be determined for the contamination in this batch.An awareness training with manufacturing operations was conducted about the risk of introducing contaminants during an intervention because of this trend.This complaint can be confirmed by the trend.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16036720
• MDR Text Key: 306838815
• Report Number: 1119779-2022-01529
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K974883
• 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: 04/06/2023

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 Model Number: 245124
• 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: 12/09/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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