MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 221261

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

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.

Event Description

It was reported by the customer that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) does not contain labeling on two package of plates.There were two occurrences in this event with no patient impact.The following information was provided by the customer: "products not containing labeling on each package of plates.".

Manufacturer Narrative

H.6 investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 221261, plate trypticase soy agar 5% sb 100 ea, batch number 2166893 and bd complaint number (b)(4) for missing sleeve labels.During manufacturing of material 221261, 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 2166893 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical and sleeve attribute testing.Sample plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical and sleeve attributes prior to release to ensure that they conform to typical levels.All physical and sleeve attribute testing performed on this batch was satisfactory per our internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 2166893.Retention samples from batch 2166893 were not available for inspection.Five photos were received for investigation.--two photos each show the top of an unopened sleeve from batch 2166893 (time stamps 0909 and 0912) with the plate print featured for batch verification.--one photo shows the side of three cartons from batch 2166893 (cartons 0002, 0008, 0020) with the carton labels featured.--two photos each show the two unopened sleeves with no sleeve label on each sleeve.No return samples were received for investigation.This product is packaged into sleeves and labeled via an automated process.If a failure in the sleeve labeling process occurs, each plate of this product is labeled so the media type, batch and expiration date are readily available.This complaint can be confirmed for missing sleeve labels.No complaint trends for labeling defects have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for labeling defects.

Event Description

It was reported by the customer that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) does not contain labeling on two package of plates.There were two occurrences in this event with no patient impact.The following information was provided by the customer: "products not containing labeling on each package of plates.".

• Brand Name: BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15323289
• MDR Text Key: 305424723
• Report Number: 1119779-2022-01152
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

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: 10/03/2022
• Device Catalogue Number: 221261
• Device Lot Number: 2166893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1