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 12/10/2021

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.

Event Description

It has been reported that four bd bbl¿ macconkey ii agars have been found contaminated.The following has been provided by the initial reporter: it was reported by the customer that there is contamination.Customer received 4 total boxes of this lot with contamination.The first two boxes were received on dec/10/2021 and the second 2 boxes were received on jan/05/2022.All boxes of the lot had plates with the contamination.Customer can not provide a total amount of plates affected.They state most of the contaminated plates were on the top of the sleeve and that 1-2 plates per sleeve were affected.They did have a couple sleeves where all 10 plates were affected.*upon visual inspection of the contaminated media was the contamination: bacteria or fungi? bacterial.On the surface or sub-surface? surface.Was the organism stained or identified? if identified, what was the species and confidence level of the identified species? gram negative rod, lactose fermenter.Not id¿d beyond that.*were any patient results affected due to the contamination? customer does not believe any patient results were affected.

Event Description

It has been reported that four bd bbl¿ macconkey ii agars have been found contaminated.The following has been provided by the initial reporter: it was reported by the customer that there is contamination.Customer received 4 total boxes of this lot with contamination.The first two boxes were received on dec/10/2021 and the second 2 boxes were received on jan/05/2022.All boxes of the lot had plates with the contamination.Customer can not provide a total amount of plates affected.They state most of the contaminated plates were on the top of the sleeve and that 1-2 plates per sleeve were affected.They did have a couple sleeves where all 10 plates were affected.*upon visual inspection of the contaminated media was the contamination: -bacteria or fungi? bacterial.-on the surface or sub-surface? surface.-was the organism stained or identified? if identified, what was the species and confidence level of the identified species? gram negative rod, lactose fermenter.Not id¿d beyond that.*were any patient results affected due to the contamination? customer does not believe any patient results were affected.

Manufacturer Narrative

H.6 investigation summary: complaint investigation during manufacturing of material 221270, 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 1305274 was 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 four other complaints have been taken on this batch for contamination.Retention samples from batch 1305274 were not available for inspection.No returns or photos were received for investigation of this complaint.Return from batch 1305274 from another customer confirmed contamination.This complaint can be confirmed.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination.Risk management file review assessed the potential risk for the defect as severity s1 per baltrmppmselectiveaph, rev 02, id 6.13.

• 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: 14017749
• MDR Text Key: 297242334
• Report Number: 1119779-2022-00511
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 10382902212703
• UDI-Public: (01)10382902212703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/28/2022
• Device Model Number: 221270
• Device Catalogue Number: 221270
• Device Lot Number: 1305274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1