• 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 BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) 2PREPARED MEDIA

  • 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 BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) 2PREPARED MEDIA Back to Search Results
Catalog Number 254058
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ haemophilus test medium agar (htm agar) there was a performance issue resulting in no growth. This was the only stated occurrence. No additional testing was mentioned. There was no indication that results were reported out, and there was no patient impact. The following information was provided by the initial reporter: update 10/25/2021: was this with patient samples or qc? patient. If patient samples - need to know if there was any erroneous results and if so - were any reported out on the patients. Were they treated based on the erroneous results? no erroneous result reported. Did this lot work previously? it was first time this customer receives this lot. Haemophilus for disc difussion does not grow.
 
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¿ haemophilus test medium agar (htm agar) catalog number 221954 which has 510k number k894216b.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR)
Type of Device2PREPARED MEDIA
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 Key12817136
MDR Text Key285352032
Report Number9680577-2021-00079
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K894216B
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2021
Device Catalogue Number254058
Device Lot Number1257478
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-