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

Catalog Number 221180

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that one bd bbl¿ sabouraud dextrose agar (deep fill) plate was contaminated prior to use.No patients were involved.The following information was provided by the initial reporter: a single plate in qc microbiology lab was discovered to have mold growth inside a newly opened sterile sleeve.Qa analyst observed mold growth on top of the agar of one sda (sabouraud dextrose agar).It was identified while performing bioburden testing.

Event Description

It was reported that one bd bbl¿ sabouraud dextrose agar (deep fill) plate was contaminated prior to use.No patients were involved.The following information was provided by the initial reporter: a single plate in qc microbiology lab was discovered to have mold growth inside a newly opened sterile sleeve.Qa analyst observed mold growth on top of the agar of one sda (sabouraud dextrose agar).It was identified while performing bioburden testing.

Manufacturer Narrative

H.6: complaint investigation: 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 1343357 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 product and its packaging does not have any sterile claims.The complaint history was reviewed, and no other complaints have been taken on batch 1343357.Retention samples from batch 1343357 were not available for inspection.Three photos were received for investigation.One photo shows the side of a sleeve from with one plate highlighted with what appears to be microbial growth in the plate.The other two photos each show a plate from batch 1343357 (time stamp 1428) with fungal growth.No return samples were received for investigation of this complaint.This complaint can be confirmed by the photos provided.This product does not have a sterile claim.No complaint trends for contamination in this product have been identified; no actions are indicated at this time.Bd will continue to trend complaints for contamination.Risk management file review assessed the potential risk for the defect as severity s1 per baltrmppmgenpuraph, rev 02, id 6.13.

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)
• Type of Device: 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: 14648117
• MDR Text Key: 301720431
• Report Number: 1119779-2022-00843
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 00382902211808
• UDI-Public: 00382902211808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/09/2022
• Device Catalogue Number: 221180
• Device Lot Number: 1343357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1