MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ LOWENSTEIN-JENSEN MEDIUM, GRUFT, SLANTS; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	297653
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.(b)(6) h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd bbl¿ lowenstein-jensen medium, gruft, slants a patient result was positive for mycobacterium tuberculosis complex (mtb).The user noted that contamination was not seen on the slants prior to use, however contamination was suspected after inoculation, as more than one patient was acid-fast bacilli (afb) positive and identified as the noted organism.The user does not have information on if there has been any patient treatment change due to the provided result.Report 3 of 5.
Additional Manufacturer Narrative
Investigation summary material 297653 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 then packed into trays and loaded onto a slant rack cart.The loaded cart is then run on a set inspissation cycle per sop.Post inspissation, tubes are packaged into final shipping configurations.The batch history record review for batch 4060566 was satisfactory per internal procedures.Filling, torquing and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on batch 4060566.Retention samples from batch 4060566 (10 tubes) were available for inspection.No media defects were observed in the retention tubes.For further investigation, retention tubes were divided and incubated at 20-25 degrees celsius (one tube) and 30-35 degrees celsius (one tube).No growth was observed at three days incubation.No photos or returns were received to assist in the investigation of this complaint.This complaint cannot be confirmed.Bd will continue to trend contamination complaints.
Event or Problem Description
It was reported while using the bd bbl¿ lowenstein-jensen medium, gruft, slants a patient result was positive for mycobacterium tuberculosis complex (mtb).The user noted that contamination was not seen on the slants prior to use, however contamination was suspected after inoculation, as more than one patient was acid-fast bacilli (afb) positive and identified as the noted organism.The user does not have information on if there has been any patient treatment change due to the provided result.Report 3 of 5.

• Brand Name: BD BBL¿ LOWENSTEIN-JENSEN MEDIUM, GRUFT, SLANTS
• Common Device Name: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19983035
• Report Number: 1119779-2024-00604
• Device Sequence Number: 11474818
• Product Code: JSJ
• UDI-Device Identifier: 30382902976531
• UDI-Public: (01)30382902976531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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
• Operator of Device: Other
• Device Expiration Date: 02/22/2025
• Device Catalogue Number: 297653
• Device Lot Number: 4060566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown