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

Model Number 245124

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/05/2023

Event Type  malfunction  

Manufacturer Narrative

Investigaion summary mgit 960 supplement kit batch 2181266 is composed of mgit panta batch 2181202 and mgit 960 growth supplement batch 2181253.The batch history record review for mgit 960 supplement kit batch 2181266 was satisfactory.No quality notifications were generated during manufacturing and no other complaints have been taken on this kit batch.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).The batch history record reviews for mgit panta batch 2181202 and mgit 960 growth supplement batch 2181253 were satisfactory and no notifications were generated during manufacturing.Qc inspection and testing were satisfactory at time of release.Retentions for panta batch 2181202 (10 vials) were available for inspection and growth supplement batch 2181253 (7 vials) were available for inspection.All 17/17 retention vials were in good condition and there was no evidence of contamination in 17/17 retention vials.For further investigation, two crimp, capped, and sealed growth supplement vials were incubated.One supplement vial was placed into 20-25-degree celsius incubation and one supplement vial was placed into 33-37-degree celsius incubation.For additional testing, two panta vials from batch 2181202 were reconstituted with two growth supplement vials from batch 2181253.One panta reconstituted with supplement was placed into the 20-25-degree celsius incubator and one reconstituted panta with supplement was placed into the 33-37-degree celsius incubator.The remaining supplement in both supplement vials that were used to reconstitute the panta were also incubated.One vial was placed into the 20-25-degree celsius incubator and one vial was placed into the 33-37-degree celsius incubator.At the end of a seven-day incubation period, no microbial growth was observed in 6/6 incubated retention vials.No photos were received to assist with the investigation.No returns were received to assist with the investigation.The complaint cannot be confirmed based on the retention investigation.Bd will continue to trend complaints for contamination/foreign material.

Event Description

It was reported that while using the bd bactec¿ mgit¿ 960 supplement kit that there was contamination.The following information was provided by the initial reporter: this is a report about foreign matter.The customer found foreign matter resembling mold in the supplement.

• 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 ; 8448235433
• MDR Report Key: 16493089
• MDR Text Key: 310967554
• Report Number: 1119779-2023-00234
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451242
• UDI-Public: 00382902451242
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023

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 Expiration Date: 12/24/2023
• Device Model Number: 245124
• Device Catalogue Number: 245124
• Device Lot Number: 2181266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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