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

Model Number 221270

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿; macconkey ii agar contamination was discovered in plate.

Manufacturer Narrative

H6: investigation summary: 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 0269572 was satisfactory at time of release 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 no other complaints have been taken on batch 0269572.Retention samples from batch 0269572 were not available for inspection.One photo was received for investigation.The photo shows the bottom of a taped plate from batch 0269572 (time stamp 1302) with a bacterial colony growing on the media.No returns were received for investigation.It is noted that batch 0269572 expired on 2020-12-18.The plate in the photo has a marking of (b)(6) 2021er applied label and the complaint was taken from the customer on (b)(6) 2021.There is no indication that the contamination was observed prior to product expiry.Bd makes no claims on expired products.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.H3 other text : see h10.

Event Description

It was reported that prior to use with bd bbl¿; macconkey ii agar contamination was discovered in plate.

• 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
• MDR Report Key: 11345645
• MDR Text Key: 242946403
• Report Number: 1119779-2021-00326
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 10382902212703
• UDI-Public: 10382902212703
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/18/2020
• Device Model Number: 221270
• Device Catalogue Number: 221270
• Device Lot Number: 0269572
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1