MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CHROMAGAR AND BBL TRYPTICASE SOY AGAR W5% SHEEP BLOOD (TSA II)-I PLATE; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 222239

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

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

Event Date 03/16/2021

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 while using bd bbl chromagar and bbl trypticase soy agar w5% sheep blood (tsa ii)-i plate foreign matter 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: "was media contamination noticed upon receiving or at a later time? upon receiving.The contamination is inside the agar itself and most were seen just upon opening the packages.Upon receiving: who is the distributor and what temperature was media shipped? fisher ¿ refrigerated.What was the storage temperature of the media? are sleeves sealed during storage? 2-5 deg, sleeves are sealed during storage.Was there any recent temperature excursions? no.Was contamination noticed before or after inoculation? some before, some after.If after inoculation, were any patient results reported? no.The contaminate was a p.Fluorescens.No cultures using this plate was reported with that organism.Was it bacteria or fungi contamination ¿ colony color?maldi result ¿ p.Fluorescens location of contamination ¿ surface or sub-surface?subsurface going through the middle partition to the top.Was organism gram stained or identified? maldi result ¿ p.Fluorescens.What was the time stamp on plate available? lot 1028433/0735/2021 0430.Lot 1028433/0736/2021 0430.Lot 1028433/1224/2021 0430.Lot 1028433/1240/2021 0430.Lot 1028433/1205/2021 0430 (worst contamination).What was the approximate quantity of product received in shipment? 4400 plates of this lot.(b)(6) 19:02:54 (gmt): reviewed, pending customer follow up (b)(6) 20:53:35 (gmt): customer problem: customer reported media 222239 contamination lot 1028433 /1205/2021 04 30.Customer reported the contamination is inside the media.".

Manufacturer Narrative

Investigation summary: 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 batch history record for batch 1028433 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 two other complaints have been taken on batch 1028433 for contamination.It is also noted that this customer has another complaint on this batch for a different defect as well for uneven fill.Retention samples from batch 1028433 were not available for inspection.Five photos were received for investigation.Three photos each show a view of a plate from batch 1028433 (time stamps 1205 and 1240 ) with subsurface and surface bacterial growth on at least one medium.No return samples were received for investigation.This complaint can be confirmed.Bd will continue to trend complaints for contamination.Due to the number of complaints taken for contamination for material 222239, a capa (corrective and preventative actions) 3076308 has been initiated to determine the root cause and corrective actions of the contamination.

Event Description

It was reported that while using bd bbl chromagar and bbl trypticase soy agar w5% sheep blood (tsa ii)-i plate foreign matter 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: "was media contamination noticed upon receiving or at a later time? upon receiving.The contamination is inside the agar itself and most were seen just upon opening the packages.Upon receiving: who is the distributor and what temperature was media shipped?fisher ¿ refrigerated.¿ what was the storage temperature of the media? are sleeves sealed during storage? 2-5 deg, sleeves are sealed during storage.¿ was there any recent temperature excursions?no.¿ was contamination noticed before or after inoculation?some before, some after ¿ if after inoculation, were any patient results reported? no.The contaminate was a p.Fluorescens.No cultures using this plate was reported with that organism.¿ was it bacteria or fungi contamination ¿ colony color?maldi result ¿ p.Fluorescens ¿ location of contamination ¿ surface or sub-surface?subsurface going through the middle partition to the top.¿ was organism gram stained or identified?maldi result ¿ p.Fluorescens ¿ what was the time stamp on plate available? lot 1028433/0735/2021 0430.Lot 1028433/0736/2021 0430.Lot 1028433/1224/2021 0430.Lot 1028433/1240/2021 0430.Lot 1028433/1205/2021 0430 (worst contamination).¿ what was the approximate quantity of product received in shipment?4400 plates of this lot (b)(6): (b)(6) 2021 19:02:54 (gmt).Reviewed, pending customer follow up.(b)(6): (b)(6) 2021 20:53:35 (gmt).¿ customer problem: customer reported media 222239 contamination lot 1028433 /1205/2021 04 30.Customer reported the contamination is inside the media.".

• Brand Name: BD BBL CHROMAGAR AND BBL TRYPTICASE SOY AGAR W5% SHEEP BLOOD (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: 11645044
• MDR Text Key: 274782975
• Report Number: 1119779-2021-00642
• 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,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 1028433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1