MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number	222239
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 while using 6 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar (tsa ii)-i plate missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported that customer reports receiving 6 222239 plates that had no plate stamp on them for identification.".
Additional Manufacturer Narrative
H.6.Investigation: during manufacturing of material 222239, 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.Three photos were received for investigation of this complaint.One photo shows the bottom of a taped bi-plate with no plate print.Another photo shows a taped stack of six bi-plates and there is no plate print on the top plate.The last photo shows the bottom of six bi-plates without a plate print on each plate.No other product labels are visible in the photos for batch verification.No return samples were received for investigation.No batch number was provided for investigation of this complaint.Retention samples cannot be evaluated without a specific batch number.Trending was performed on the appropriate quality databases and no trends for missing plate print were found in the last 12 months.The complaint history was reviewed for material 221270 and there are no complaint trends for missing plate print over the last 12 months.This complaint cannot be confirmed.Bd will continue to trend for this issue.
Event or Problem Description
It was reported that while using 6 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar (tsa ii)-i plate missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported that customer reports receiving 6 222239 plates that had no plate stamp on them for identification.".

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿
• Common Device Name: CULTURE MEDIA, NON-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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12271301
• Report Number: 1119779-2021-01278
• Device Sequence Number: 14574319
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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 Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: UNKNOWN
• 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: 07/08/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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