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U.S. Department of Health and Human Services

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
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BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Catalog Number 251239
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2023
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) that there was biological contamination.The following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, bacterial growth was found in the media before usage.
 
Manufacturer Narrative
H.3.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 while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) that there was biological contamination.The following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, bacterial growth was found in the media before usage.
 
Manufacturer Narrative
H.6 investigation summary: (b)(6) we could confirm this issue as a report from photo.No samples were returned.This issue was contamination.We couldn't conduct further investigation due to no returned sample.No issue in retention and device history record.No trend.Root cause was undetermined.H3 other text : see h.10.
 
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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 Key17758908
MDR Text Key323684386
Report Number1119779-2023-01000
Device Sequence Number1
Product Code JSG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2023
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 Date09/21/2023
Device Catalogue Number251239
Device Lot Number3143197
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/24/2023
Initial Date FDA Received09/15/2023
Supplement Dates Manufacturer Received11/02/2023
Supplement Dates FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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