MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR WITH KANAMYCIN AND VANCOMYCIN (KV); CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Model Number 221736

Device Problem Contamination (1120)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that while using 100 bd bbl cdc anaerobe 5% sheep blood agar with kanamycin and vancomycin (kv) bacterial 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: "bacterial (based on photo review)".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: during manufacturing of material 221736, 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 batch 2118857 was 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 no other complaints have been taken on batch 2118857.Retention samples from batch 2118857 were not available for inspection.Two photos were received for investigation.One photo shows a sleeve from batch 2118857 with at least two broken plates within the sleeve.The second photo shows the top of an unopened sleeve with what appears to be a colony of growth visible in the top plate within the sleeve.The top plate is also broken.No return samples were received for investigation.Review of the manufacturing record for this batch did not find a cause for broken plates from the production.This complaint can be confirmed for broken plates and contamination.This product does not have a sterile claim and no other complaints have been taken on this batch for contamination.No complaint trends for broken plates or contamination have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for broken plates and contamination.

Event Description

It was reported that while using 100 bd bbl¿ cdc anaerobe 5% sheep blood agar with kanamycin and vancomycin (kv) bacterial 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: "bacterial (based on photo review)".

• Brand Name: BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR WITH KANAMYCIN AND VANCOMYCIN (KV)
• Type of Device: CULTURE MEDIA, SELECTIVE AND NON-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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15135834
• MDR Text Key: 304448559
• Report Number: 1119779-2022-01045
• Device Sequence Number: 1
• Product Code: JSJ
• UDI-Device Identifier: 10382902217364
• UDI-Public: 10382902217364
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K803022
• 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: 10/18/2022

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: 07/15/2022
• Device Model Number: 221736
• Device Catalogue Number: 221736
• Device Lot Number: 2118857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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