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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE CHOCO GC AG W/ISOVITALEX 90MM 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY EXCLUDING MUELLER HINTON

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BECTON DICKINSON GMBH PLATE CHOCO GC AG W/ISOVITALEX 90MM 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY EXCLUDING MUELLER HINTON Back to Search Results
Catalog Number 254060
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Event Description
It was reported that while using 130 plate choco gc ag w/isovitalex 90mm 20 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: "the quantity of plates detected contaminated with mold is 130 out of 1200. ".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. 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 is a class ii, 510(k) exempt device.
 
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Brand NamePLATE CHOCO GC AG W/ISOVITALEX 90MM 20
Type of DeviceCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY 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 Key12660975
MDR Text Key284187059
Report Number9680577-2021-00063
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeIT
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 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2021
Device Catalogue Number254060
Device Lot Number1211473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2021
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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