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: BD KIESTRA LAB AUTOMATION BD KIESTRA INOQULA; DEVICE, MICROTITER DILUTING/DISPENSING
  • 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
 

BD KIESTRA LAB AUTOMATION BD KIESTRA INOQULA; DEVICE, MICROTITER DILUTING/DISPENSING Back to Search Results
Catalog Number 447202
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2024
Event Type  malfunction  
Manufacturer Narrative
H3.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 the bd kiestra inoqula did not dispense sample on plates resulting in no growth.There was no health impact or consequences reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD KIESTRA INOQULA
Type of Device
DEVICE, MICROTITER DILUTING/DISPENSING
Manufacturer (Section D)
BD KIESTRA LAB AUTOMATION
6 marconilaan
drachten KY
Manufacturer (Section G)
BD KIESTRA LAB AUTOMATION
6 marconilaan
drachten KY
Manufacturer Contact
jo doyka
7 loveton circle
sparks, MD 21152
4103164000
MDR Report Key18722776
MDR Text Key336622728
Report Number3010141591-2024-00002
Device Sequence Number1
Product Code JTC
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number447202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-