MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MACCONKEY II AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number 221270

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported by the customer that they found about 20 plates of, bd bbl¿ macconkey ii agar that were heavily contaminated.This occurred one time in this event and there was no patient impact.The following information was provided by the customer, "on (b)(6) 2022, we received 7 cases (100 plates/ca) of item # 221270 (lawson # 6320871) on po #12657243 from cardinal.We have found about 20 plates that are heavily contaminated with what appears to be a mixture of organisms.These were from lot#: 209147 (exp 07/07/22) with various time stamps on them, ranging from 1945 to 1954.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.

Manufacturer Narrative

H.6 investigation summary: during manufacturing of material 221271, 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 review for batch 2146002 a satisfactory and no quality notifications were generated during manufacturing and inspection.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 one other complaint has been taken on batch 2146002 for contamination.Retention samples from batch 2109300 were not available for investigation.No photos or return samples were received for investigation of this complaint.This complaint cannot be confirmed.There is no photo to verify the batch.H3 other text : see h.10.

Event Description

It was reported by the customer that they found about 20 plates of, bd bbl¿ macconkey ii agar that were heavily contaminated.This occurred one time in this event and there was no patient impact.The following information was provided by the customer, "on 06/02/22 we received 7 cases (100 plates/ca) of item # 221270 (lawson # 6320871) on po #12657243 from cardinal.We have found about 20 plates that are heavily contaminated with what appears to be a mixture of organisms.These were from lot # 209147 (exp 07/07/22) with various time stamps on them, ranging from 1945 to 1954.

• Brand Name: BD BBL¿ MACCONKEY II AGAR
• Type of Device: CULTURE MEDIA, 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14881936
• MDR Text Key: 302024861
• Report Number: 1119779-2022-00950
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 10382902212703
• UDI-Public: 10382902212703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 221270
• Device Catalogue Number: 221270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• 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