MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING

Model Number 245124

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/25/2021

Event Type  malfunction  

Event Description

It was reported that while using 2 bd bactec¿ mgit¿ 960 supplement kit mold contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "the customer found that the media was contaminated with bacteria resembling mold upon mixing the supplement and the panta.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using 2 bd bactec¿ mgit¿ 960 supplement kit mold contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " the customer found that the media was contaminated with bacteria resembling mold upon mixing the supplement and the panta.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 03-dec-2021.H.6 investigation summary: mgit 960 supplement kit batch 1161188 is composed of mgit panta batch 1161152 and mgit 960 growth supplement batch 1154511.The batch history record review for mgit 960 supplement kit batch 1161188 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 1161152 and mgit 960 growth supplement batch 1154511were satisfactory and no notifications were generated during manufacturing.Qc inspection and testing were satisfactory at time of release.Retention samples from panta batch 1161152 (10 vials) were available for inspection.No microbial growth was observed from visual inspection of 10/10 retention vials.Retention samples from growth supplement batch 1154511 (6 vials) were available for inspection.No microbial growth was observed in 6/6 retention samples from visual inspection.For investigation of the complaint, one panta retention vials was reconstituted with one growth supplement retention vial as per the package insert instructions for this kit product and incubated at 20 to 25 degrees c.Another panta retention vial was reconstituted with one growth supplement retention vial and incubated at 33 to 37 degrees c.At seven days incubation, no growth was observed in the vials incubated.Return samples were received for investigation.Two panta vials from batch 1161152 and one growth supplement vial from batch 1154511 in a plastic bag were returned in a box with bubble wrap and returns for two other complaints.The two growth supplement vials returned did not have crimps or stoppers and did not contain any media.The crimps around the stoppers of both panta vials had been removed and the panta media were reconstituted.Within the panta vials, fungal growth was observed.The vial was submitted to the id lab and the fungal growth was identified as a mold but was no longer viable for further identification.Five photos also were received for investigation.One photo shows two panta vials with reconstituted media and what appears to be fungal growth in the media.One photo shows two growth supplement vials from batch 1154511 without crimps or stoppers and two panta vials without crimps around the stoppers.Two photos each show a close-up of reconstituted media in a vial with what appears to be fungal growth featured in the media.The last photo features the batch labels of two panta vials from batch 1161152 for batch verification.This complaint can be confirmed for contamination.A complaint trend for contamination was identified on kit batch 1161188.Investigation of the trend found mold from environmental monitoring during production of growth supplement batch 1154511.The mold observed during environmental monitoring did not exceed levels to trigger an action per bd procedures.Due to the complaint trend, manufacturing operations investigated the observed mold and did not find a root cause.Manufacturing operations conducted a retraining event with manufacturing associates for aseptic technique and in-process bioburden reduction as a corrective action.Manufacturing operations also identified opportunities for improvement that are being investigated as well.Bd will continue to trend complaints for contamination.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer (Section G): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13053181
• MDR Text Key: 286761523
• Report Number: 1025402-2021-00008
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

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: 11/25/2022
• Device Model Number: 245124
• Device Catalogue Number: 245124
• Device Lot Number: 1161188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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