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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD PLATE HTM AGAR 90MM 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

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BECTON DICKINSON GMBH BD PLATE HTM AGAR 90MM 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 10/01/2021
Event Type  malfunction  
Event Description
It was reported that while testing patient sample with bd plate htm agar 90mm 20 there was no growth of haemophilus influenzae. Results were not reported and there was no patient impact. The following information was provided by the initial reporter: no growth on htm for this lot, the customer sees very regularly that there is no growth of haemophilus influenzae on htm. Were patient samples involved? yes. Was it clear to the customer that there was something wrong? yes. Were any erroneous results provided to the clinician? no, it was abnormal that there was no growth. We replaced the batch by another batch.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 PLATE HTM AGAR 90MM 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12720694
MDR Text Key281415265
Report Number9680577-2021-00065
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeBE
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 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number254058
Device Lot Number1187036
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2021
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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