MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE TSA L&P80 RODAC

Catalog Number 221288

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

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 plate tsa l&p80 rodac fungal contamination was discovered on 16 plates.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-14.H6: investigation summary: this memo is to summarize findings in regards to your complaints related to, catalog number 221288, plate tsa l&p80 rodac 20 ea, batch number 0254315 and complaint #2239840 for contamination.During manufacturing of material 221288, media is formulated using the dehydrated culture media (dcm) with usp purified water.Media is then processed through a high temperature short time sterilizer to remove bioburden and is aseptically dispensed directly into rodac dishes.Personnel working in the filling area are required to wear full body jumpsuits, hoods, boots, masks and gloves.Dispensing and sleeving are completed within iso certified environment.The filled plates are cooled and immediately wrapped 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 0254315 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 no other complaints have been taken on this batch for contamination.Retention samples from batch 0254315 were not available for inspection.Five photos were received in lieu of returns for investigation.One photo shows a sleeve from batch 0254318 that appears to be unopened with fungal growth on the surface of the top plate in the sleeve.The second and fifth photo each show the agar surface of an opened plate from batch 0254315 (time stamp 1237) with fungal growth on the media surface.The third photo shows the side of a sleeve from batch 0254313 with fungal growth visible in at least five of the plates within the sleeve.The fourth photo shows the agar surface of 10 rodac plates with fungal growth on each plate.Bd will continue to trend complaints for contamination.This complaint has been confirmed.This product does not have a sterile claim.The number of affected plates reported for this batch is within acceptable levels for this product.No corrective actions are indicated at this time.Tsa with l&p80 in rodac dishes are available in gamma-irradiated sterile pack formats for critical environments.

Event Description

It was reported that prior to use with plate tsa l&p80 rodac fungal contamination was discovered on 16 plates.

• Brand Name: PLATE TSA L&P80 RODAC
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11238550
• MDR Text Key: 230073288
• Report Number: 1119779-2021-00148
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/13/2021
• Device Catalogue Number: 221288
• Device Lot Number: 0254315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1