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

Model Number 221267

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

Patient Problem Insufficient Information (4580)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

It was reported that while using 3 bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) atypical growth 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: " weak growth of organisms.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.Investigation summary: 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 0281098, 0260862, 0226666 and 0212671 were satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Chocolate ii agar is stability tested annually for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on the batches in question were satisfactory at the time of release.The complaint history was reviewed and no other complaints have been taken on batches 0281098, 0260862, 0226666 and 0212671 for performance.Retention samples from batches 0281098, 0260862, 0226666 and 0212671 were not available for inspection.Customer test data was received.The data describes organisms tested on batch 0281098 where the growth on batch 0281098 was not as good when compared to growth on other media.Four photos also were received for investigation.Each photo is a collage of two plates, one chocolate brown agar plate and one medium red agar plate.Each photo shows the agar surface of the two plates with streak lines visible on each plate and each medium red agar plate has more growth than the chocolate brown agar plate (described as a plate from batch 0281098).It is followed that the photos are showing the chocolate agar has less growth as compared to the other media used.However, this investigation cannot make conclusions about performance from photos alone.Returns were not received for investigation.No other complaints were taken for performance from the batches in question and review of the batch history records were satisfactory.It is noted that batches 022666 and 0212671 expired on 2020-12-08 and 2020-11-24, respectively.This complaint was taken on (b)(6) 2021.Bd makes no claims on expired products.This complaint cannot be confirmed for a performance defect on the batches in question.Bd will continue to trend complaints for performance.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0260862, medical device expiration date: 2021-01-15, device manufacture date: 2020-09-16.Medical device lot #: 0226666, medical device expiration date: 2020-12-08, device manufacture date: 2020-08-13.Medical device lot #:0212671, medical device expiration date: 2020-11-24, device manufacture date: 2020-07-30.

• 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
• MDR Report Key: 12397776
• MDR Text Key: 280527149
• Report Number: 1119779-2021-01464
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: 10382902212673
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 08/27/2021

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 Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1