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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, HEAVY FILL STERILE
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BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR, HEAVY FILL STERILE Back to Search Results
Catalog Number 292396
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
It was reported that 197 bd bbl¿ trypticase¿ soy agar, heavy fill sterile plates from lot 1214894, and 1 plate from lot 1260098 had pre-existing, embedded colonies in their agar.There was no report of user or patient impact.The following information was provided by the initial reporter: "customer reporting embedded particles in product 292396 - plate sterile tsa heavy fill." "customer reports plates are unusable due to existing embedded colonies in the agar."colonies" are not visualized until after the incubation periods of 3-5 days at 20-25 degrees celsius and 2-3 days at 30-35 degrees celsius.This impacts the facility environmental monitoring program and corresponding production planning." "197 plates from lot 1214894; 1 plate from lot 1260098.".
 
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1214894, medical device expiration date: 2022-01-14,and device manufacture date: 2021-08-21; medical device lot #: 1260098, medical device expiration date: 2022-03-03,and device manufacture date: 2021-10-03.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Correction: after further review, it was found that this is a luo kit (laboratory use only) and is not a registered medical device in the us.This product is also not an accessory device to the bd max instrument.Therefore, this complaint will be cancelled.
 
Event Description
It was reported that 197 bd bbl¿ trypticase¿ soy agar, heavy fill sterile plates from lot 1214894, and 1 plate from lot 1260098 had pre-existing, embedded colonies in their agar.There was no report of user or patient impact.The following information was provided by the initial reporter: "customer reporting embedded particles in product 292396 - plate sterile tsa heavy fill." "customer reports plates are unusable due to existing embedded colonies in the agar."colonies" are not visualized until after the incubation periods of 3-5 days at 20-25 degrees celsius and 2-3 days at 30-35 degrees celsius.This impacts the facility environmental monitoring program and corresponding production planning." "197 plates from lot 1214894; 1 plate from lot 1260098".
 
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Brand Name
BD BBL¿ TRYPTICASE¿ SOY AGAR, HEAVY FILL STERILE
Type of Device
NA
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 Key13543328
MDR Text Key288480715
Report Number1119779-2022-00245
Device Sequence Number1
Product Code JSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number292396
Device Lot NumberSEE SECTION H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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