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	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 20 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: has the product been used for patient testing and were there any adverse effects if used? no.Customer problem: customer reporting contamination in product 220909 lot 0092841, tube lowenstein, jensen med sl a.Steps taken with customer/troubleshooting:  initiated complaint; reportedly contaminated upon arrival.
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 0092841 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and torquing processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history has been reviewed and there are no other complaints on this batch.Retention samples from batch 0092841 (10 tubes) were available for inspection.There was no evidence of contamination observed in 10/10 retention samples.For investigation, two retention tubes went into incubation.One tube was incubated at 20 to 25 degrees celsius, and one tube was incubated at 33 to 37 degrees celsius.No microbial growth was observed in 2/2 retention tubes at seven days incubation.No photos were received for the investigation.No returns were received to assist with the investigation.Bd will continue to trend complaints for contamination.This complaint cannot be confirmed.H3 other text : see h10.
Event or Problem Description
It was reported that while using 20 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: " has the product been used for patient testing and were there any adverse effects if used? no customer problem: customer reporting contamination in product 220909 lot 0092841 - tube lowenstein-jensen med sl a.* steps taken with customer/troubleshooting:  initiated complaint; reportedly contaminated upon arrival ".

• 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
• MDR Report Key: 11653783
• Report Number: 1119779-2021-00654
• Device Sequence Number: 3546814
• Product Code: KZI
• UDI-Device Identifier: 30382902209097
• UDI-Public: 30382902209097
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2021

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: 09/25/2021
• Device Model Number: 220909
• Device Catalogue Number: 220909
• Device Lot Number: 0092841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 09/18/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1