MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR W/5% SB(TSA II) /MAC II AGAR; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221291

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 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(4).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 the bd bbl¿ trypticase soy agar w/5% sb(tsa ii) /mac ii agar plates are contaminated.

Manufacturer Narrative

Investigation summary: during manufacturing of material 221291, 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 0304047 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and 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.One other complaint has been taken on batch 0304047 for contamination and no other complaints have been taken on batch 0304047 for broken plates.Retention samples from batch 0304047 were not available for inspection.Two photos were received for investigation.One photo shows six opened bi-plates with bacterial colonies on at least one media of each plate.No returns were received for investigation.The other photo shows five opened plates from batch 0304047 (time stamps 0607, 0612 and 0613), the bottom of one plate with the plate print featured for batch verification (time stamp 0613) and a sleeve label from batch 0304047.The opened plates in the photo each have bacterial colonies growing on at least one media.No returns were received for investigation.No broken or cracked plates from batch 0304047 were shown in the photos.This complaint cannot be confirmed for broken plates.This complaint can be confirmed for contamination.Bd will continue to trend complaints for broken plates and contamination.Based on the low defect rate for this batch, no actions are planned at this time.

Event Description

It was reported that the bd bbl¿ trypticase soy agar w/5% sb(tsa ii) /mac ii agar plates are contaminated.

• Brand Name: BD BBL TRYPTICASE SOY AGAR W/5% SB(TSA II) /MAC II AGAR
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11316004
• MDR Text Key: 242945810
• Report Number: 1119779-2021-00293
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 10382902212918
• UDI-Public: 10382902212918
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 09/01/2021

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: 02/10/2021
• Device Model Number: 221291
• Device Catalogue Number: 221291
• Device Lot Number: 0304047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1