MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA.; CULTURE MEDIA, ENRICHED

Model Number	220909
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using 17 bd bbl¿ lowenstein-jensen medium slants 100 ea.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: "i hereby report that tubes with microbial growth have been detected among the culture media received a few weeks ago.".
Event or Problem Description
It was reported that while using 17 bd bbl¿ lowenstein-jensen medium slants 100 ea.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: "i hereby report that tubes with microbial growth have been detected among the culture media received a few weeks ago.".
Additional Manufacturer Narrative
Investigation summary: material 220909 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 0050130 was satisfactory and no notifications were generated during manufacturing and inspection.Filling, torquing and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.Qc inspection and testing were satisfactory at time of release.The complaint history for this batch was reviewed and no other complaints have been taken on this batch.Retention samples from batch 0050130 were not available for inspection.Two photos were received to assist with the investigation: the first photo shows the front of one partial tube.The batch can be partially seen.The batch can be verified as 0050130.The overall color of the slant is light green to light blue green.The media in the photo does not appear to be contaminated.The media does appear to be poorly mixed.Also noted the cap in this photo cannot be seen.The second photo shows a partial tube.The focus is on the media.The overall color of the slant is light green to light blue green.The media does not appear to be contaminated.However, the appearance of the media does appear to be poorly mixed.No product information can be seen in this photo.The cap in this photo also cannot be seen.No returns were received to assist with the investigation.This complaint cannot be confirmed by the photos provided.Bd will continue to trend complaints for contamination.

• Brand Name: BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA.
• Common Device Name: CULTURE MEDIA, ENRICHED
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12249159
• Report Number: 1119779-2021-01235
• Device Sequence Number: 17309389
• Product Code: KZI
• UDI-Device Identifier: 30382902209097
• UDI-Public: 30382902209097
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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
• Operator of Device: Other
• Device Expiration Date: 08/14/2021
• Device Model Number: 220909
• Device Catalogue Number: 220909
• Device Lot Number: 0050130
• 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: 06/30/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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