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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEP TEST, EXCL MUELLER HINTON

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BECTON DICKINSON GMBH BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEP TEST, EXCL 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 10/08/2021
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ haemophilus test medium agar 2 plates had no colony growth. The following information was provided by the initial reporter: no colony growth on plate 2 plates were tested from a positive blood culture but there was no colony growth after incubation in co2.
 
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 number 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 BBL¿ HAEMOPHILUS TEST MEDIUM AGAR
Type of DeviceCULTURE MEDIA, ANTIMICROBIAL SUSCEP TEST, EXCL 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 Key12780185
MDR Text Key285054520
Report Number9680577-2021-00076
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K894216B
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 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
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? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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