MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING

Model Number 245122

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

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported that during use with bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, false results were obtained.Confirmatory ziehl-neelsen staining was performed.Erroneous results were not reported out, and there was no report of patient impact.The following information was provided by the initial reporter: reported as resistant to isoniazid after removing the tube from the kit and the presence of mycobacterium tuberculosis complex was confirmed the growth of the m.Tuberculosis complex was not detected in the tube containing isoniazid in the antibiogram.The growth is observed with the naked eye (as seen in the photo), and the presence of the complex in the tube containing isoniazid was confirmed with ziehl neelsen staining.

Manufacturer Narrative

Note: device expiration date (03/20/2021) predates the date of event (b)(6) 2022.Initial reporter phone number: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary material 245122 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued, and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 9267735 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation and filling processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures and checks for torque confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 9267735 were available for inspection.The batch is expired.Three photos were received to assist with the investigation: first photo shows two tubes from batch 9267735.The tubes appear as expected.The second photo shows a computer screenshot of some results.The last photo shows a graph curve of some results.No returns were received for investigation.Retains could not be tested, as they were expired.This complaint is unable to be confirmed based on the investigation completed.The complaint was taken 06/15/2022, the batch expired 2021-03-20.Bd makes no claims on expired products.Bd will continue to trend complaints for performance.H3 other text : see h.10.

Event Description

It was reported that during use with bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, false results were obtained.Confirmatory ziehl-neelsen staining was performed.Erroneous results were not reported out, and there was no report of patient impact.The following information was provided by the initial reporter: reported as resistant to isoniazid after removing the tube from the kit and the presence of mycobacterium tuberculosis complex was confirmed the growth of the m.Tuberculosis complex was not detected in the tube containing isoniazid in the antibiogram.The growth is observed with the naked eye (as seen in the photo), and the presence of the complex in the tube containing isoniazid was confirmed with ziehl neelsen staining.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
• 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: 15022156
• MDR Text Key: 302000516
• Report Number: 1119779-2022-00994
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/20/2021
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 9267735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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