MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR SETTLING PLATES

Catalog Number 222205

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 11/29/2020

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 bd bbl¿ trypticase¿ soy agar settling plates growth was discovered on 10 plates.

Event Description

It was reported that prior to use with bd bbl¿ trypticase¿ soy agar settling plates growth was discovered on 10 plates.

Manufacturer Narrative

H6: investigation summary material 222205 is manufactured by rehydrating the dehydrated culture media (dcm) with usp purified water.The media is then processed through a high temperature short time sterilizer to remove bioburden and is aseptically dispensed directly into petri dishes.The petri dishes are then sealed into clean sleeves and boxed.Personnel working in the filling area are required to wear full body jumpsuits, hoods, boots, masks and gloves.The filled plates are cooled and immediately wrapped to decrease the introduction of microbes.Dispensing and sleeving are completed within an iso certified environment.Sleeves are packed into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the irradiator, product is then shipped to our customers and distributors via refrigerated truck.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media 2 to 8 degrees c in a dark place.The batch history record review for batch 0183482 was satisfactory per internal procedures.The release testing that is performed on this product was satisfactory per our internal procedures.Review of processing and irradiation records indicates the processing and gamma irradiation dose were within our specified parameters.Environmental monitoring results for this manufacturing period were within our guidelines.Our sterile pack prepared plated media products have been validated to a sterility assurance level (sal) of 10^-6 using the american national standard ansi/aami/iso 11137-1994, sterilization of health care products-requirements for validation and routine control-radiation sterilization dose setting method 2a as a guideline.As part of the sal claim, the identified processes and monitoring results are reviewed for conformance to predetermined validation criteria and product specifications, including confirmation that each product batch was irradiated within our validated dose range.If all specifications are met, the product batch is released.Quarterly dose audits are conducted on a representative product from the sterile pack prepared plated media product line to ensure that the bioburden remains below the pre-determined level which established the dose range for the sal claim of 10^-6.The release testing also includes inspection for physical attributes.Sample plates are tested for physical attributes prior to release to ensure they conform to typical levels.All physical attribute testing performed on this batch, including sleeve attributes, was satisfactory per our internal procedures.The the complaint history was reviewed, and no other complaints have been taken for on batch 0183482 contamination or appearance.Retention samples from batch 0183482 were not available for inspection.Three photos were received in lieu of returns for investigation.The first photo features a sleeve label from batch 0183482 for batch verification.The other two photos each show dried surface moisture on a plate from batch 0183482 (time stamp 0735).The main component of prepared plated media is purified water.The purified water is held in an agar matrix in the media.Release of the purified water as the matrix contracts during temperature cycling and progression through shelf life is referred to as exudation.Other components of the media may be exuded along with the water.This may appear to be small media particles on the agar.See h10.

• Brand Name: BD BBL TRYPTICASE SOY AGAR SETTLING PLATES
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11293549
• MDR Text Key: 232013853
• Report Number: 1119779-2021-00265
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/25/2021

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: 12/15/2020
• Device Catalogue Number: 222205
• Device Lot Number: 0183482
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1