• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD PLATE CHOCO GC AGAR W/ISOVITALEX 90MM CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON GMBH BD PLATE CHOCO GC AGAR W/ISOVITALEX 90MM CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST 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 11/16/2021
Event Type  malfunction  
Event Description
It was reported that while using 4 bd plate choco gc agar w/isovitalex 90mm by the laboratory personnel. A cepheid test was used to confirm the results as false positives. 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: "customer found 4 contaminated bd chocolate agar plates with visible bacterial growth prior to use of those plates. ".
 
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 has 510k k945569.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PLATE CHOCO GC AGAR W/ISOVITALEX 90MM
Type of DeviceCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12980821
MDR Text Key289199292
Report Number9680577-2021-00094
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeIS
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 Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/20/2021
Device Catalogue Number254089
Device Lot Number1264059
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 Manufactured09/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-