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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), PLATE, 90 MM X 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

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BECTON DICKINSON GMBH BD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM), PLATE, 90 MM X 20 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 11/22/2021
Event Type  malfunction  
Event Description
It was reported while testing with bd¿ haemophilus test medium agar (htm), plate, 90 mm x 20, there was no growth on media. Confirmatory testing was performed using a different media, and colonies grew correctly. There was no report of patient impact. 100 cases were affected. The following information was provided by the initial reporter, translated from (b)(6): the cultures plates aren't working properly. There is no colony growth on the plates. An alternative test has been carried out on other media and the colonies are growing correctly.
 
Manufacturer Narrative
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, with 510k # k894216b. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM), PLATE, 90 MM X 20
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13029121
MDR Text Key290307650
Report Number9680577-2021-00099
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
SEE H10
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 04/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
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 Received04/11/2022
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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