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

Catalog Number 221278

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ sabouraud dextrose agar (deep fill) is contaminated.Customer states the contamination is mold.No patient impact was reported.The following information was provided by the initial reporter: customer states product is contaminated.Bacteria or fungi contamination ¿ colony color? customer states mold.

Event Description

It was reported that bd bbl¿ sabouraud dextrose agar (deep fill) is contaminated.Customer states the contamination is mold.No patient impact was reported.The following information was provided by the initial reporter: customer states product is contaminated.Bacteria or fungi contamination ¿ colony color? customer states mold.

Manufacturer Narrative

H.6 investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 221278, plate sabouraud dextrose agar 100 ea, batch number 2235322 and bd complaint number (b)(4) for contamination.During manufacturing of material (b)(4), 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 2235322 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 2235322.Retention samples from batch 2235322 were not available for inspection.Two photos were received for investigation.One photo shows the top of a sleeve with what appears to be fungal growth in the top plate.The other photo shows the side of a sleeve from batch 2235322 with what appears to be fungal growth in the top plate.Return samples were not received for investigation.This complaint can be confirmed for contamination.Bd has identified a contamination trend for this product.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination.

• 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: 15645681
• MDR Text Key: 304811781
• Report Number: 1119779-2022-01324
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/27/2023
• Device Catalogue Number: 221278
• Device Lot Number: 2235322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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