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 11/29/2023

Event Type  malfunction  

Event Description

It was reported that the bd bactec¿ mgit¿ 960 supplement kit had foreign matter inside.No report of patient impact.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H3.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 the bd bactec¿ mgit¿ 960 supplement kit had foreign matter inside.No report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: the components of kit batch 3180624 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.Retention samples were inspected for panta batch 3180592 (10 vials).There were no foreign materials observed in 10/10 retention samples inspected.Supplement retentions were not available for inspection.For further investigation two panta vials from batch 3180592 were reconstituted with 3ml of sterile water.One panta vial reconstituted with 3ml sterile water was placed into 20-25-degrees celsius incubator; and one panta vial reconstituted with 3ml sterile water was placed into 33-37-degrees celsius incubator.At the end of a 14-day incubation period no microbial growth was observed in 2/2 incubated retention vials.One photo was received to assist with the investigation.The photo shows one vial of reconstituted panta with growth in the vial, batch 3145445 exp 2024-11-17.No returns were received to assist with the investigation.This complaint cannot be confirmed.The photo does not verify the batch for this complaint.Bd will continue to trend complaints for contamination defects.

• 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: 18367305
• MDR Text Key: 331068053
• Report Number: 1025402-2023-00047
• 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: 04/03/2024

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: 3180624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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