MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H10; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 222239

Device Problem Contamination (1120)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿.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 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.It is best to do these 2 to 3 hours directly before you inoculate the plates (see warnings and precautions section of your product insert where applicable).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.If this is observed at your site, please contact technical services and document the occurrence with photographs as soon as possible after it is noticed.The batch history record for batch 1106169 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 three other complaints have been taken on this batch for contamination including two others from this customer for different shipments ((b)(4)).Retention samples from batch 1106169 were not available for inspection.One photo was received for investigation of this complaint.The photo shows three sleeves from batch 1106169 with one sleeve that has blue in the chromagar orientation medium of one plate presumably due to growth in the medium.No condensation or free moisture is seen in the sleeves in the photo.Returns from batch 1106169 were received for (b)(4) and contamination was observed and identified as pseudomonas fluorescens and serratia liquefaciens.Excess moisture was not observed in those returns.Bd will continue to trend complaints for defects.The complaint can be confirmed for contamination.Capa # (b)(4) (corrective and preventative actions) has been initiated to determine the root cause and corrective actions of the contamination.

Event Description

It was reported that prior to use with bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ 30 plates had visible contamination.The following information was provided by the initial reporter: customer reports receipt of 222239 lot 1106169: plate bi chromagar orient/tsa ii sb 100 with visible contamination.

• Brand Name: SEE H10
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12407671
• MDR Text Key: 269379984
• Report Number: 1119779-2021-01466
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• 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
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/12/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 1106169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• 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