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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT; SEE H.10
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BECTON DICKINSON GMBH BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT; SEE H.10 Back to Search Results
Catalog Number 254089
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2023
Event Type  malfunction  
Manufacturer Narrative
Common device name: culture media, antimicrobial susceptibility test, excluding mueller hinton.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¿ gc ii agar with isovitalex¿ enrichment slow growth occurred.The following information was provided by the initial reporter: no growth of species such as e.G.Stpah.Slow growth, poor performance.
 
Event Description
It was reported that bd bbl¿ gc ii agar with isovitalex¿ enrichment slow growth occurred.The following information was provided by the initial reporter: no growth of species such as e.G.Stpah.Slow growth, poor performance.
 
Manufacturer Narrative
H.6 investigation summary: this memo is to summarize the findings related to your complaint (b)(4) against chocolate agar (gc ii agar with isovitalex¿); catalog number 254089; lot number 2333148.Event description: the customer is reporting no growth of species such as e.G.Staph.Slow growth, poor performance.It is a centre very much affected by bo of culture media with a recently awarded tender.Issue occurred with patient samples (not qc samples).Complaint history review: the complaint history record has been reviewed and similar issue were recorded.However, no trend was identified.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: the performance tests on retention samples of the above-mentioned batch according to the specifications of the certificate of analysis resulted in excellent growth of the following strains: - neisseria gonorrhoeae atcc 43069 - neisseria meningitidis atcc 13090 - haemophilus influenzae atcc 10211 - staphylococcus epidermidis atcc 12228 - streptococcus pneumoniae atcc 6305 - granulicatella adiacens dsm 9848 after an incubation of 24 to 48h at 36°c ± 1°c in co2 atmosphere.Neither samples nor pictures illustrating the issue were shared evaluation results: at this stage of our investigation, we have excluded any systemic failure in our production process.No deviation could be found during the qc performance test.No abnormality was detected during the review of batch history record.Investigation conclusion: based on the above-mentioned evaluation and since no pictures illustrating the issue were shared, the complaint was not confirmed.H3 other text : see h.10.
 
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Brand Name
BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
Type of Device
SEE H.10
Manufacturer (Section D)
BECTON DICKINSON GMBH
8-12 tullastrasse
heidelberg 69126
GM  69126
Manufacturer (Section G)
BECTON DICKINSON GMBH
8-12 tullastrasse
heidelberg 69126
GM   69126
Manufacturer Contact
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16461260
MDR Text Key310696268
Report Number9680577-2023-00008
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K945569
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 03/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2023
Device Catalogue Number254089
Device Lot Number2333148
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2022
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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