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

Model Number 221284

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 01/07/2021

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 biological contamination - bacterial, fungal was found on the non-viable bd bbl" xld agar.There was no report of patient impact.The following information was provided by the initial reporter.Customer reports that xld plates received for po# (b)(4) are contaminated; all plates are affected.Molds-like formations are seen on close observation of these plates.

Manufacturer Narrative

Investigation summary: during manufacturing of material 221284, 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 0297714 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, and two other complaints have been taken on batch 0297714 for foreign material.Retention samples from batch 0297714 were not available for inspection.Six photos were received for investigation.The first photo shows nine opened sleeves.Another photo features two sleeve labels from batch 0297714 for batch verification.The other four photos are similar; each shows the bottom of a plate from batch 0297714 (time stamp 2211) with particles in the media.No returns were received for investigation.The particles in the photos are consistent with bile salt precipitate.Bile salts (sodium desoxycholate) are a component of the medium.Throughout shelf-life bile salts may crystalize and present as white particles on the agar surface or within the media.The presence of crystallized bile salts should not affect the performance of the product.The complaint has been confirmed.Bd will continue to trend complaints for precipitates and foreign materials.Based on the low defect rate for this batch, no actions are planned at this time.

Event Description

It was reported that biological contamination - bacterial, fungal was found on the non-viable bd bbl¿ xld agar.There was no report of patient impact.The following information was provided by the initial reporter.Customer reports that xld plates received for po# 193151 are contaminated; all plates are affected.Molds-like formations are seen on close observation of these plates.

• Brand Name: BD BBL XLD AGAR
• Type of Device: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11244881
• MDR Text Key: 231406478
• Report Number: 1119779-2021-00161
• Device Sequence Number: 1
• Product Code: JSJ
• UDI-Device Identifier: 10382902212840
• UDI-Public: 10382902212840
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/19/2021
• Device Model Number: 221284
• Device Catalogue Number: 221284
• Device Lot Number: 0297714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1