MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿); CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Catalog Number 221267

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

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

It was reported that the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) experienced biological contamination which was observed by laboratory personnel.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: contamination was reported.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1195885, medical device expiration date: 2021-11-09, device manufacture date: 2021-07-14.Medical device lot #: 1231218, medical device expiration date: 2021-12-14, device manufacture date: 2021-08-24.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) experienced biological contamination which was observbed by laboratory personnel.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: contamination was reported.

Manufacturer Narrative

H.6.Investigation summary: complaint investigation.During manufacturing of material 221267, 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 batches 1195885 and 1231218 were satisfactory per internal procedures.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 no other complaints have been taken on either batch 1195885 or batch 1231218.Retention samples from batches 1195885 and 1231218 were not available for inspection.Two photos were received for investigation.One photo shows the bottom of a plate from batch 1231218 (time stamp 1714) with the plate print featured for batch verification.The other photo shows the agar surface of a plate with two large colonies of growth.No photos of plates from batch 1195885 and no return samples were received for investigation.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.This complaint can be confirmed by the trend for both batches.Bd will continue to trend complaints for contamination.Risk management file review assessed the potential risk for the defect as severity 1 per baltrmppmgenpuraph, rev 02, id 6.13.

• Brand Name: BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿)
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• 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: 12832425
• MDR Text Key: 280949815
• Report Number: 1119779-2021-01843
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 00382902212676
• UDI-Public: 00382902212676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• 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,Followup
• Report Date: 09/01/2022

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 Catalogue Number: 221267
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 09/15/2022
• 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