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

Model Number 222239

Device Problem Contamination (1120)

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

Event Date 06/22/2021

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.Medical device lot #: 1106174.Medical device expiration date: 2021-07-13.Device manufacture date: 2021-04-16.

Event Description

It was reported that while using bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (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: the petri dish was damaged.Incomplete media filling.The medium has been contaminated.Lot 1099123,1106174: incomplete media filling.The medium has been contaminated and discolor.

Manufacturer Narrative

H6: investigation: 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 batches 1085486, 1099123 and 1106174 were satisfactory and no quality notifications were generated during manufacturing and inspection of each batch.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 these batches were 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 batches 1085486, 1099123 and 1106174 from other customers.Retention samples from batches 1085486, 1099123 and 1106174 were not available for inspection.Three photos were received for investigation.One photo shows the bottom of a plate from batch 1099123 (time stamp 1127) with what appears to be microbial growth in one bi-plate half.One photo shows the bottom of five plates from batch 1106174 (time stamps 0720, 0723, 0725 and 0727) with mixed media in one bi-plate half of each plate.One photo shows the bottom of a plate from batch 1085486 (time stamp 1405) with media splash over that has resulted in mixed media in one bi-plate half and media that does not completely fill the other bi-plate half.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 in batch 1099123 and media splash over in batches 1106174 and 1085486 from the photos provided for this investigation.Broken plates and contamination in batch 1085486, media splash over in batch 1099123 and contamination in batch 1106174 can be confirmed from photos provided in other complaints.Due to the number of complaints taken for contamination for material 222239, capa #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 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (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: "the petri dish was damaged.Incomplete media filling.The medium has been contaminated lot 10991231106174: incomplete media filling.The medium has been contaminated and discolor.".

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR
• 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: 12250288
• MDR Text Key: 264277677
• Report Number: 1119779-2021-01249
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/13/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 1106174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/08/2022
• 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