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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 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

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BECTON DICKINSON GMBH BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON Back to Search Results
Catalog Number 254089
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Manufacturer Narrative
There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u. S. Marketed device bd bbl¿ gc ii agar with isovitalex¿ enrichment catalog number 221240 which ha 510k number k945569. 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 10 plates of bd bbl¿ gc ii agar with isovitalex¿ enrichment were discovered to contaminated. The following information was provided by the initial reporter, translated from (b)(6) to english: ten plates were found to be contaminated.
 
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Brand NameBD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
Type of DeviceCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12774686
MDR Text Key285835612
Report Number9680577-2021-00074
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeNL
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 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2021
Device Catalogue Number254089
Device Lot Number1244923
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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