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 Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 that three bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) were missing labels.No patient impact reported.

Manufacturer Narrative

H.6.Investigation summary: the batch history record for batch 3285323 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 testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 3285323.Retention samples from batch 3285323 were not available for inspection.One photo was received for investigation.The photo shows four unopened sleeves of medium red agar plates.Three of the sleeves do not have a sleeve label visible.One of the sleeves pictured has a sleeve label but the information on the label cannot be read due to the quality of the photo.Shipping data was reviewed, it was verified batch 3285323 was shipped to lotte biologics.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 number and expiration date are readily available.This complaint can be confirmed.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 that three bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) were missing labels.No patient impact reported.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18366414
• MDR Text Key: 331060729
• Report Number: 1119779-2023-01385
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902212615
• UDI-Public: (01)30382902212615
• 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: 01/25/2024

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: 02/05/2024
• Device Catalogue Number: 221261
• Device Lot Number: 3285323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1