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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MUELLER HINTON II BROTH, CATION-ADJUSTED; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MUELLER HINTON II BROTH, CATION-ADJUSTED; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST Back to Search Results
Model Number 212322
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default initial reporter phone number: (b)(6).Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0252334.Medical device expiration date: 2024-04-30.Device manufacture date: 2020-09-08.Medical device lot #: 1089790.Medical device expiration date: 2025-02-28.Device manufacture date: 2021-03-30.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 while using bd bbl¿ mueller hinton ii broth, cation-adjusted bacterial contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " contamination of their powder is ver obvious to the batches 0252334 and 1089790.".
 
Manufacturer Narrative
H.6 investigation summary components are milled and blended (where required), and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur, which include dispensing into and labeling of final configurations, followed by transport to the distribution center.The complaint investigation included a review of the batch history records.The batch history record review indicated no discrepancies.All release testing was satisfactory for both lots.Release testing includes dehydrated medium appearance, solution appearance, ph, and biological performance with organisms as specified on the bd certificate of analysis.The complaint trends were reviewed for a period covering 12 months.During that time, there have been no confirmed complaints on this product for the defect in question.No returns or photos were received.Bd does not claim sterility of mueller hinton ii broth cation dcm and does not maintain data regarding bioburden of this material.
 
Event Description
It was reported that while using bd bbl¿ mueller hinton ii broth, cation-adjusted bacterial contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " contamination of their powder is ver obvious to the batches 0252334 and 1089790.".
 
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Brand Name
BD BBL¿ MUELLER HINTON II BROTH, CATION-ADJUSTED
Type of Device
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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 Key15089235
MDR Text Key304610708
Report Number1119779-2022-01020
Device Sequence Number1
Product Code JTZ
UDI-Device Identifier00382902123224
UDI-Public00382902123224
Combination Product (y/n)N
Reporter Country CodeGM
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 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number212322
Device Catalogue Number212322
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
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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