• 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 AND COMPANY BD BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; 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 AND COMPANY BD BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Model Number 221742
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2019
Event Type  malfunction  
Event Description
False-positive gram stain.There were no positive cultures from any specimens that were inoculated into this medium, indicated that these cells seen in this medium were non-viable.Manufacturer response for general-purpose medium for cultivation of microorganisms, bd bbl thioglycollate medium, enriched with vitamin k1 and hemin (per site reporter).Bd tech services: they assigned a case number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
Type of Device
CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
7 loveton circle
sparks MD 21152
MDR Report Key8802602
MDR Text Key151455563
Report Number8802602
Device Sequence Number1
Product Code JSG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/03/2019
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 No Information
Device Model Number221742
Device Catalogue Number221742
Device Lot Number9087634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2019
Event Location Hospital
Date Report to Manufacturer07/18/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/18/2019
Type of Device Usage N
Patient Sequence Number1
Patient Age24820 DA
-
-