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 Contamination (1120)

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

Event Date 11/06/2022

Event Type  malfunction  

Event Description

It was reported that bd bbl¿ chromagar¿ orientation agar (100 shelf pack) contamination occurred.The following information was provided by the initial reporter: customer reported biological contamination in some of the chromagar orientation plates from lots 2242577 (exp.2022/12/27) and 2250551 (exp.2023/01/05).Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 2242577.Medical device expiration date: 27-dec-2022.Device manufacture date: 30-aug-2022.Medical device lot#: 2250551.Medical device expiration date: 01-jan-2023.Device manufacture date: 07-sep-2022.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

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 review for batches 2242577 and 2250551 were satisfactory per internal procedures.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, an no other complaints have been taken on batch 2242577.The complaint history was reviewed, and no other complaints have been taken for batch 2250551 for contamination.No retention samples for this batch were available for investigation.Three photos were received.Photo one shows six plates, two plates with contamination (id 2250551 timestamps 0103 and 0050) and four plates with media fallout (id 2250551, timestamps 1418, 1416 and two illegible timestamps).Photo two shows four contaminated plates (id 2242577 timestamps 1945, 2006, 2012 and 2005).Photo three shows four total plates, three contaminated plates (id 2242577 timestamps 2114, 2005 and illegible) and one plate with media fallout (id 2242577, timestamp 1801).No return samples were received for investigation of this complaint.This complaint can be confirmed for contamination and media fallout.Bd has identified a contamination trend for this product and the investigation found opportunities for bioburden reduction in the manufacturing process.

Event Description

It was reported that bd bbl¿ chromagar¿ orientation agar (100 shelf pack) contamination occurred.The following information was provided by the initial reporter: customer reported biological contamination in some of the chromagar orientation plates from lots 2242577 (exp.2022/12/27) and 2250551 (exp.2023/01/05).Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

• 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: 15841306
• MDR Text Key: 307089396
• Report Number: 1119779-2022-01412
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902150814
• UDI-Public: 10382902150814
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 215081
• Device Catalogue Number: 215081
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1