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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
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BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Catalog Number 221716
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2023
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ trypticase¿ soy broth contamination was observed.There was no patient impact.The following was rpeorted by the initial reporter: according to the customer's report, recently, in smear tests using the broth, a small amount of g+r or g-r are indistinctly observed.Today, a gram staining was performed with centrifugal sedimentation from several unused tubes, and g-r was observed.The bacteria was found in the lower part of the tubes.No bacteria was found in the upper part.The customer suspects environmental bacteria.Occurred with 5 plates.
 
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.
 
Manufacturer Narrative
H6: investigation summary: the batch history record review for batch 3005708 was satisfactory per internal procedures.Formulation, filling, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing was satisfactory at time of release.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 3005708 (10 tubes) were available for inspection.No cap, tube, or media defects were observed in 10/10 retention samples.All retentions tubes had the expected appearance for this product of light to medium light yellow, trace hazy to clear.For investigation, two retention tubes went into incubation.One tube was placed in 20-25-degree celsius incubation and one tube was placed in 33-37-degrees celsius incubation.At the end of a seven-day incubation period no microbial growth was observed in 2/2 incubated retention tubes.No photos or returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination/appearance and non-viable defects.
 
Event Description
It was reported that while using bd bbl¿ trypticase¿ soy broth contamination was observed.There was no patient impact.The following was rpeorted by the initial reporter: according to the customer's report, recently, in smear tests using the broth, a small amount of g+r or g-r are indistinctly observed.Today, a gram staining was performed with centrifugal sedimentation from several unused tubes, and g-r was observed.The bacteria was found in the lower part of the tubes.No bacteria was found in the upper part.The customer suspects environmental bacteria.Occurred with 5 plates.
 
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Brand Name
BD BBL¿ TRYPTICASE¿ SOY BROTH
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 Key17725555
MDR Text Key323299382
Report Number1119779-2023-00977
Device Sequence Number1
Product Code JSG
UDI-Device Identifier30382902217160
UDI-Public30382902217160
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 11/01/2023
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 Catalogue Number221716
Device Lot Number3005708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2023
Initial Date FDA Received09/11/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received11/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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