MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MUELLER HINTON AGAR WITH 5% SHEEP BLOOD; SEE H.10

Model Number	221275
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	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bbl¿ mueller hinton agar with 5% sheep blood has had 3 low ph reads on different occasions.The following information was provided by the initial reporter: customer report media 221176 low ph with three reading taken 7.06 ,7.11,7.13.
Additional Manufacturer Narrative
D2a: common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.H.3.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 bd bbl¿ mueller hinton agar with 5% sheep blood has had 3 low ph reads on different occasions.The following information was provided by the initial reporter: customer report media 221176 low ph with three reading taken 7.06 ,7.11,7.13.
Additional Manufacturer Narrative
Investigation summary: during manufacturing of material 221176, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record for batch 3073513 was satisfactory and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Mueller hinton ii agar is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batch 3073513.Retention samples from batch 3073513 were not available for inspection.Two return shipments of batch 3073513 samples were received for investigation.One unopened sleeve (ten plates) was received on may 15, 2023 in a biohazard shipping kit (time stamp 1509).Another unopened sleeve (10 plates) was received on may 22, 2023 in an insulated box with ice packs and returns for three other batches (time stamp 1510).Return samples were ph tested and the average ph of six plates was 7.3.The ph specification for this product is 7.2 to 7.4 when taken at 23 to 27 degrees c.No photos were received for investigation.The ph of the product may vary depending on the age of the product and the type of ph meter and probe used, however return samples tested within ph specifications.This complaint cannot be confirmed.Bd will continue to trend complaints for ph variance.

• Brand Name: BD BBL¿ MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
• Common Device Name: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16959436
• Report Number: 1119779-2023-00577
• Device Sequence Number: 5243563
• Product Code: JTZ
• UDI-Device Identifier: 10382902212758
• UDI-Public: 10382902212758
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/05/2023

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: 06/21/2023
• Device Model Number: 221275
• Device Catalogue Number: 221275
• Device Lot Number: 3073513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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