MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR (TSA II)-I PLATE; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 222239

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: this memo is to summarize findings regarding the complaint related to, catalog number 222239, plate bi chromagar orient/tsa ii sb 100 ea, batch number 1099123 and complaint (b)(4) for contamination.During manufacturing of material 222239, 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 main component of prepared plated media is purified water.The purified water is held in an agar matrix in the media.Release of the purified water as the matrix contracts during temperature cycling and progression through shelf life is referred to as exudation.As media progresses through shelf life, some condensate will appear inside the sleeves, dishes or on the agar surface.This condensate or excessive moisture occasionally presents upon removal from storage and packaging.Plates can be inverted over the lid and allowed to dry before inoculation when condensate/excessive moisture is noted.Control of the temperature cycling that our product experiences while in your possession may help reduce the amount of free moisture seen.Pooling of water inside the sleeve is not considered a normal amount of excessive moisture.The batch history record for batch 1099123 was satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute and bioburden testing.Sample 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 typical levels.All physical attribute and bioburden testing performed on this batch was satisfactory per our internal procedures.The plates in question are not sterile.They are tested for bioburden prior to release to ensure that they conform to typical levels.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and four other complaints have been taken on this batch for contamination.This customer has an additional complaint on this batch, pr 2859556, for another shipment for contamination, media splash over, broken plates and excess moisture.Retention samples from batch 1099123 were not available for inspection.Four photos were received for investigation of this complaint.One photo shows a sleeve from batch 1099123 with blue in the chromagar orientation medium of at least one plate in the photo.Another photo shows the agar surface of an opened plate with blue-colored growth in the chromagar orientation medium.The last two photos each show plate bottom or agar surface of a plate from batch 1099123 (time stmap 1517) with subsurface growth in the tsa with 5% sheep blood agar.Returns also were received for investigation of (b)(4).The returned plates showed contamination that was identified as pseudomonas fluorescens and stenotrophomonas rhizophila were identified.Bd will continue to trend complaints for defects.This complaint can be confirmed for the contamination.A contamination trend for batch 1099123 has been identified.A corrective and preventive action (capa) has been initiated to determine the root cause and corrective actions.

Event Description

It was reported that while using 230 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar (tsa ii)-i plate¿ contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer reports receipt of contaminated plates for item 222239 lot 1099123 - plate bi chromagar orient/tsa ii sb.".

• Brand Name: BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR (TSA II)-I PLATE
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 12388887
• MDR Text Key: 281202686
• Report Number: 1119779-2021-01457
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/06/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 1099123
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1