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

Model Number	221180
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd bbl¿ sabouraud dextrose agar (deep fill) experienced missing label information.The following information was provided by the initial reporter: missing a label.
Event or Problem Description
It was reported that the bd bbl¿ sabouraud dextrose agar (deep fill) experienced missing label information.The following information was provided by the initial reporter: missing a label.
Additional Manufacturer Narrative
H.6 investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 221180, plate sabouraud dextrose agar 20 ea, batch number 1238261 and complaint number (b)(4).For missing label.During manufacturing of material 221180, 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 1238261 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 testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch, including sleeve attributes, was satisfactory per bd internal procedures.The complaint history was reviewed, and the only other complaint on batch 1238261 was also from evonik for a different defect (complaint number (b)(4)., missing plate).Retention samples from batch 1238261 were not available for inspection.Three photos were received for investigation.One photo shows the top of an opened 20pack carton.Another photo shows the side of a carton from batch 1238261 (carton number 0101) with the carton label featured for batch verification.The last photo shows two sleeves from batch 1238261 with one sleeve that has a sleeve label and another sleeve that does not appear to have a sleeve label.No return samples were received for this investigation.This product is packaged into sleeves and labeled via an automated process.If a failure in the sleeve labeling process occurs, each plate of this product is labeled so the media type, batch and expiration date readily available.This complaint can be confirmed.No complaint trends for labeling defects have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for labeling defects.

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12657196
• Report Number: 1119779-2021-01675
• Device Sequence Number: 4869181
• Product Code: JSI
• UDI-Device Identifier: 10382902211805
• UDI-Public: 10382902211805
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/25/2022

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 Expiration Date: 01/25/2022
• Device Model Number: 221180
• Device Catalogue Number: 221180
• Device Lot Number: 1238261
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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