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 Contamination of Device Ingredient or Reagent (2901)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) contamination on plates occurred.No patient impact occurred.The following information was provided by the initial reporter: customer reported contaminated plate of product 221261 lot no.3152962.

Manufacturer Narrative

H.6.Investigation summary: the batch history record for batch 3152962 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 no other complaints have been taken on batch 3152962.Retention samples from batch were not available for inspection.Ten plates from batch 3152962 were returned as one unopened sleeve shipped in a box with air bubbles.Plates were inspected and 0/10 plates had microbial growth (time stamp 2001).For investigation of this complaint, returned plates were incubated at 33 to 37 degrees c.At 3 days incubation, 0/10 plates had growth.One photo also was received for investigation.The photo shows the bottom of one plate from batch 3152962 (time stamp 1957) with the plate print featured for batch verification and the agar surface of another plate with a colony of growth.This complaint can be confirmed for contamination by the photo provided.Due to the low defect rate (1 plate reported) for this batch; no actions are indicated at this time.Bd will continue to trend complaints for contamination.

Event Description

It was reported that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) contamination on plates occurred.No patient impact occurred.The following information was provided by the initial reporter: customer reported contaminated plate of product (b)(4).Lot no.3152962.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547453
• MDR Text Key: 321524804
• Report Number: 1119779-2023-00886
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: 09/26/2023
• Device Catalogue Number: 221261
• Device Lot Number: 3152962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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