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 06/18/2021

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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1085486, medical device expiration date: 2021-06-24, device manufacture date: 2021-03-26.Medical device lot #: 1099123, medical device expiration date: 2021-07-06, device manufacture date: 2021-04-09.

Event Description

It was reported that while using 30 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: "lot 1085486: the medium has been contaminated.Lot 1099123: the medium has been contaminated and discolor.".

Manufacturer Narrative

H6: 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 records for batch 1085486 and 1099123 were satisfactory 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.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and 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 other complaints have been taken on batch 1085486 and 1099123 from other customers.Retention samples from batches 1085486 and 1099123 were not available for inspection.Five photos were received for investigation.--one photo shows the top plate of three stacks from batch 1085486 (time stamp 0917).One top plate is broken and another plate has mixed media in one bi-plate half.--one photo shows the top plate in a stack from batch 1099123 (time stamp 1116) with subsurface microbial growth in the tsa with 5% sheep blood agar.--one photo shows the bottom of a plate from batch 1099123 (time stamp 1628) with mixed media in both bi-plate halves.--one photo shows the top plate in a stack from batch 1099123 (time stamp 1556) with microbial growth in the chromagar orientation agar.--one photo shows stacks of plates with microbial growth and mixed media visible.No return samples were received for investigation.Media splash over is a filling defect were the two media of a bi-plate are mixed in at least one half of the bi-plate.This results in media appearing discolored and in unevenly filled halves of the bi-plate.This complaint can be confirmed for contamination and media splash over in batch 1099123 by the photos provided.The photos provided can confirm broken plates and media splash over in batch 1085486.Contamination was not seen in batch 1085486 in the photos provided for this investigation.However, photos from other complaints have shown contamination in this batch.Contamination has been confirmed in batch 1085486.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.Bd will continue to trend complaints for these defects.

Event Description

It was reported that while using 30 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: " lot 1085486: the medium has been contaminated lot 1099123: the medium has been contaminated and discolor.".

• 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
• 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: 12178043
• MDR Text Key: 261957754
• Report Number: 1119779-2021-01179
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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