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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM) CULTURE MEDIA ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

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BECTON DICKINSON GMBH BD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM) CULTURE MEDIA ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON 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 10/27/2021
Event Type  malfunction  
Manufacturer Narrative
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 6 bd¿ haemophilus test medium agar (htm) plates failed to grow haemophilus colonies. There was no adverse patient impact. The following information was provided by the initial reporter, translated from (b)(6) to english: "no growth from hämophilus. " "did the issue happen with patient samples? yes. Was it obvious to the customer that the results were erroneous? yes - no growth no result. Were erroneous results reported to the clinician? no growth no result. Were patients treated based on erroneous results? no growth no result. If yes, was there any adverse impact on patients? no result no treated. ".
 
Manufacturer Narrative
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 6 bd¿ haemophilus test medium agar (htm) plates failed to grow haemophilus colonies. There was no adverse patient impact. The following information was provided by the initial reporter, translated from (b)(6) to english: "no growth from hämophilus. " "did the issue happen with patient samples? yes. Was it obvious to the customer that the results were erroneous? yes - no growth no result. Were erroneous results reported to the clinician? no growth no result. Were patients treated based on erroneous results? no growth no result. If yes, was there any adverse impact on patients? no result no treated. ".
 
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Brand NameBD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM)
Type of DeviceCULTURE MEDIA ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
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 Key12855022
MDR Text Key286116831
Report Number9680577-2021-00085
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeGM
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 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
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 Received11/24/2021
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

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