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

Model Number 222239

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 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar foreign matter was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Event Description

It was reported that while using bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar foreign matter was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

Investigation: during manufacturing of material 222239, 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 records for batches 0044951 and 0324225 were satisfactory at time of release.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 the only other complaints taken on either batches 0044951 or 0324225 were also taken from this customer for contamination and other defects.Retention samples from batches 0044951 and 0324225 were not available for inspection.One photo was received for investigation.The photo shows the bottom of four taped plates from batch 0324225 (time stamps 2055, 2114, 2117 and 2204) with one microbial colony visible on the chromagar orientation medium of each plate.No return samples were received for this complaint.It is noted that batch 0044951 expired on 2020-05-13 and this complaint was taken on january 27, 2021.Bd makes no claims on expired products.However, previous complaints for contamination taken from this customer were before product expiration and were confirmed for contamination.This complaint can be confirmed for contamination for both batches in question.Bd will continue to trend complaints for contamination.Due to the number of complaints taken for contamination for material 222239, capa#3076308 has been initiated to determine the root cause and corrective actions of the contamination.

• Brand Name: BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11363306
• MDR Text Key: 241153017
• Report Number: 1119779-2021-00348
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/22/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 0324225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1