MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Model Number	221240
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	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ gc ii agar with isovitalex¿ enrichment 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: " 2 plates show single colony growing on the medium.Detected before usage of the plates ".
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.(b)(6).
Event or Problem Description
It was reported that while using bd bbl¿ gc ii agar with isovitalex¿ enrichment 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: " 2 plates show single colony growing on the medium.Detected before usage of the plates.".
Additional Manufacturer Narrative
H6: investigation summary: during manufacturing of material 221240, media is formulated using the dehydrated culture media (dcm) with usp purified water.Media is then processed through a high temperature short time sterilizer to remove bioburden and is aseptically dispensed directly into petri dishes.Personnel working in the filling area are required to wear full body jumpsuits, hoods, boots, masks and gloves.Dispensing and sleeving are completed within iso certified environment.The filled plates are cooled and immediately wrapped 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 1026609 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All 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 1026609.Retention samples from batch 1026609 were not available for inspection.Two photos were received for investigation.One photo shows the bottom of two plates from batch 1026609 (time stamps 0132 and 0133) with one microbial colony in each plate visible.The other photo shows the agar surface of the same two plates to feature the colony growing.No return samples were received for investigation.This complaint can be confirmed.No trend for contamination has been identified for this product; no actions are planned at this time.Bd will continue to trend complaints for contamination.

• Brand Name: BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
• Common Device Name: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11959198
• Report Number: 1119779-2021-00959
• Device Sequence Number: 19756072
• Product Code: JSO
• UDI-Device Identifier: 10382902212406
• UDI-Public: 10382902212406
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K945569
• 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): 11/05/2021

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: 06/23/2021
• Device Model Number: 221240
• Device Catalogue Number: 221240
• Device Lot Number: 1026609
• 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: 05/12/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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