MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ HEKTOEN ENTERIC AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number	221366
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	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ hektoen enteric agar contamination occurred.The following information was provided by the initial reporter: "after unpacking, bacteria have grown in the medium.".
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.
Additional Manufacturer Narrative
H.6 investigation summary: during manufacturing of material 221366, 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 2221363 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and bioburden testing performed on this batch was satisfactory per bd internal procedures.Affected product does not have any sterility claims; the product is.Tested for bioburden prior to release to ensure that it conforms to product specifications.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed and no other complaints have been taken on batch 2221363 for dried/split agar and low fill.No retention samples for batch 2221363 were available for inspection.Five photos were received for investigation.One photo shows several plates, one with split agar (time stamp 0755), one with dried agar (time stamp 0755), and one with contamination (time stamp 0755) from batch 2221363.The second photo shows two plates from batch 2221363 with contamination ( one with time stamp 0755).A third photo shows contamination on one agar plate from batch 2221363 visible (time stamp 0755) and another agar plate with thin agar (batch number and time stamp not visible).A fourth photo shows two plates with thin, dried agar and agar bed fallout (batch number and time stamp not visible).The last photo shows the top of a plate from batch 2221363 (time stamp 0755) with media on the sides.The plate does not appear to have not been filled.The complaint for contamination, split agar, dried agar, and agar bed fallout can be confirmed.No complaint trends for this defect(s) have been identified; no actions are indicated at this time.
Event or Problem Description
It was reported that while using bd bbl¿ hektoen enteric agar contamination occurred.The following information was provided by the initial reporter: "after unpacking, bacteria have grown in the medium.".

• Brand Name: BD BBL¿ HEKTOEN ENTERIC AGAR
• Common Device Name: CULTURE MEDIA, SELECTIVE AND 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: 15677037
• Report Number: 1119779-2022-01340
• Device Sequence Number: 6369370
• Product Code: JSI
• UDI-Device Identifier: 10382902213663
• UDI-Public: 10382902213663
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• 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): 01/30/2023

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: 11/10/2022
• Device Model Number: 221366
• Device Catalogue Number: 221366
• Device Lot Number: 2221363
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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