Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 DE MEXICO PLATE TSA SB 5% 100MM 10EA; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
  • 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 DE MEXICO PLATE TSA SB 5% 100MM 10EA; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Catalog Number 220150
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  malfunction  
Event Description
It was reported that plate tsa sb 5% 100mm 10ea shows different coloration.The following information was provided by the initial reporter: the trypticaena soy agar plate with 5% blood shows different coloration in the same lot number.
 
Manufacturer Narrative
Initial reporter address: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 9614033-2022-00117was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
 
Event Description
It was reported that plate tsa sb 5% 100mm 10ea shows different coloration.The following information was provided by the initial reporter: the trypticaena soy agar plate with 5% blood shows different coloration in the same lot number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PLATE TSA SB 5% 100MM 10EA
Type of Device
CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16035425
MDR Text Key308373936
Report Number9614033-2022-00117
Device Sequence Number1
Product Code JSG
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
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 01/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/11/2023
Device Catalogue Number220150
Device Lot Number2227922
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received12/14/2022
Supplement Dates FDA Received01/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-