MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD DIFCO¿ MUELLER HINTON AGAR; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Catalog Number	225250
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd difco¿ mueller hinton agar that there was the following information was provided by the initial reporter that there was no label or missing label information.'we received bd mueller hinton ref.(b)(4) but it isn¿t ce marked as expected? the label mentions ¿for lab use only¿ but for human clinical it would need to be ce marked.I thought that i would receive product with the new label which is multi folded to allow them to have all european languages including preparation instructions.".
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.E.6 initial reporter e-mail: (b)(6).H.3.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: the complaint investigation included a review of the batch history record (bhr) for bottle mueller hinton agar 500g, batch 2060506.All qc release testing including dehydrated medium appearance, solubility, prepared plate appearance, ph, and cultural response with those organisms specified on the bd certificate of analysis was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time, there have been no other complaints received on this product for any defects.No photos or returns were received or required for investigation.The customer stated that they received material (b)(4), lot 2060506 without a ce mark as expected.The ce mark is required for those products as determined by the device classification; devices that are marketed as medical devices and maintain ivd claims per eu ivdr would require this symbol on the product labeling.Bottle mueller hinton agar, 225250 is labeled "for laboratory use" and is not intended to be used for ivd purposes.Bd continually monitors products throughout the product lifecycle to ensure that they are properly classified.This complaint cannot be confirmed.
Event or Problem Description
It was reported that while using bd difco¿ mueller hinton agar that there was the following information was provided by the initial reporter that there was no label or missing label information.'we received bd mueller hinton ref.225250 but it isn¿t ce marked as expected? the label mentions ¿for lab use only¿ but for human clinical it would need to be ce marked.I thought that i would receive product with the new label which is multi folded to allow them to have all european languages including preparation instructions.".

• Brand Name: BD DIFCO¿ MUELLER HINTON AGAR
• Common Device Name: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17671273
• Report Number: 1119779-2023-00966
• Device Sequence Number: 20390552
• Product Code: JTZ
• UDI-Device Identifier: 00382902252504
• UDI-Public: 00382902252504
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 06/30/2024
• Device Catalogue Number: 225250
• Device Lot Number: 2060506
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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