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

Catalog Number 245124

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 12/07/2023

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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.

Event Description

The customer reported while using the bd bactec¿ mgit¿ 960 supplement kit, there was an unidentified floating substance found in the supplement.This was found before use and there was no report of any impact to patient or user.

Event Description

The customer reported while using the bd bactec¿ mgit¿ 960 supplement kit, there was an unidentified floating substance found in the supplement.This was found before use and there was no report of any impact to patient or user.

Manufacturer Narrative

H.6.Investigation summary: mgit 960 supplement kit batch 3187776 is composed of mgit panta batch 3187758 and mgit 960 growth supplement batch 2342081.The batch history record review for mgit 960 supplement kit batch 3187776 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 standard operating procedures.Six mgit panta vials are then manually packaged with six mgit growth supplement vials to make a mgit 960 supplement kit (material 245124).The components of kit batch 3187776 were reviewed and all batch history records were satisfactory at time of release per internal procedures.Performance of each kit component was satisfactory per procedures.For this product, retention samples are maintained as individual components and no complete cartons were available for inspection.Retention samples were inspected for growth supplement batch 3187766 (8 vials) and panta batch 3187758 (10 vials) and no media defects were observed in any of these retention samples inspected.For further investigation two panta batch 3187758 vials were reconstituted with 3ml sterile water.The reconstituted panta with sterile water had a hazy yellow appearance, which was the normal appearance upon reconstitution 3ml of sterile water with panta.Two panta batch 3187758 reconstituted with 15ml growth supplement batch 3187766.The reconstituted panta with supplement had a trace hazy yellow appearance, which was the normal appearance upon reconstitution with 15ml growth supplement.The reconstituted panta vials (2) were placed into the 20-25-degrees celsius incubator (remaining supplement in the supplement vial and the), and (2) panta reconstituted with growth supplement (remaining supplement in the supplement vial was also incubated) was placed into the 33-37-degrees celsius incubator.At the end of a seven-day incubation period no growth was observed in 4/4 incubated retention vials.The panta with supplement incubated vials had a trace hazy yellow appearance and the panta with sterile water incubated vials had a hazy yellow appearance.These were the normal appearances of panta reconstituted with growth supplement and with sterile water.Three photos were received to assist with the investigation.One photo shows uncrimped reconstituted vial of batch 3187758.One photo shows close up of vial with shadowy dark solution.One photo shows kit label batch 3187776.No returns were received to assist with the investigation.This complaint can be confirmed based on the evidence provided from the photos.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18425249
• MDR Text Key: 331798436
• Report Number: 1025402-2023-00048
• 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,Followup
• Report Date: 04/08/2024

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: 3187776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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