MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR SLANTS; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Model Number	220958
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bbl¿ middlebrook and cohn 7h10 agar slants were contaminated.There was no report of patient impact.One slant was affected.The following information was provided by the initial reporter: it was reported by the customer that there was "a contaminated agar slant.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: material 220958 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The media is then heat processed within a sterilization module per standard operating procedure (sop).Heat sensitive components are added during filling.Filling, capping and torqueing are performed within the aseptic processing area mechanically.Once the slants have solidified, the tubes are then labeled in a separate packaging area.The batch history record review for batch 1182157 was satisfactory and no notifications were generated during manufacturing and inspection.Formulation and filling processes were within specifications.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include bioburden testing.Samples are incubated at 25 degrees c and at 35 degrees c for 28 days.All bioburden testing performed on this batch was satisfactory per our internal procedures.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 1182157 (10 tubes) were available for investigation.No subsurface particles or microbial growth was observed in 10/10 retention samples.For investigation of the complaint, the retentions were incubated for a 21-day incubation period with the caps loosened.One retention tube was placed into 33-37-degree incubation, and one tube was placed into 20-25-degree incubation.No microbial growth or sub surface particles were observed after incubation in 2/2 retention samples.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.Components are prepared, combined, and dispensed aseptically but there is no final sterilization step after dispensing.The manufacturing process has been designed to minimize bioburden and qc inspection includes bioburden testing prior to release.Additionally, in-process inspections are conducted during manufacturing, and particles or foreign materials are to be rejected per procedures.However, there is no guarantee that the end user will not receive a contaminated tube or that all tubes will be free of defects.H3 other text : see h.10.
Event or Problem Description
It was reported that bd bbl¿ middlebrook and cohn 7h10 agar slants were contaminated.There was no report of patient impact.One slant was affected.The following information was provided by the initial reporter: it was reported by the customer that there was "a contaminated agar slant.".

• Brand Name: BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15166977
• Report Number: 1119779-2022-01066
• Device Sequence Number: 2109041
• Product Code: JSJ
• UDI-Device Identifier: 30382902209585
• UDI-Public: 30382902209585
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/18/2022

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: 12/23/2022
• Device Model Number: 220958
• Device Catalogue Number: 220958
• Device Lot Number: 1182157
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 09/18/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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