MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR (100 SHELF PACK); CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 215081

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

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

Event Date 01/20/2022

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 the bd bbl¿ chromagar¿ orientation agar (100 shelf pack) experienced atypical growth.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: customer states this is not contamination but an unusual organism growing on the plate.Customer is not concerned with blood and mac plates having no growth.They described the growth as tiny, dark blue colonies.Customer reports that subculture from chromagar to blood plate was also no growth at 24hrs and 48hrs at 37c.Per customer, all plates were inadvertently discarded and can't provided additional information.Customer did not provide information on results reported to patient.Customer unable to replate specimen as it was already discarded.Discussed with customer the possibility of a workflow issue when plating the specimen, a possible contaminant, an inhibiting substance, or a contaminant.Customer state product was not contaminated when inoculated.

Manufacturer Narrative

H6 investigation summary: during manufacturing of material 215081, 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 1333736 was satisfactory and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Chromagar orientation medium is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batch 1333736.Retention samples from batch 1333736 were not available for inspection.No return samples or photos were received for investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for performance defects.

Event Description

It was reported that the bd bbl¿ chromagar¿ orientation agar (100 shelf pack) experienced atypical growth.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: customer states this is not contamination but an unusual organism growing on the plate.Customer is not concerned with blood and mac plates having no growth.They described the growth as tiny, dark blue colonies.Customer reports that subculture from chromagar to blood plate was also no growth at 24hrs and 48hrs at 37c.Per customer, all plates were inadvertently discarded and can't provided additional information.Customer did not provide information on results reported to patient.Customer unable to replate specimen as it was already discarded.Discussed with customer the possibility of a workflow issue when plating the specimen, a possible contaminant, an inhibiting substance, or a contaminant.Customer state product was not contaminated when inoculated.

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR (100 SHELF PACK)
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13537074
• MDR Text Key: 292039392
• Report Number: 1119779-2022-00243
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902150814
• UDI-Public: 10382902150814
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/25/2022
• Device Model Number: 215081
• Device Catalogue Number: 215081
• Device Lot Number: 1333736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1