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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING

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BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 245122
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
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 the labels were missing from bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml. This occurred with 10 tubes. The following information was provided by the initial reporter, translated from (b)(6) to english: the tube does not have any labeling stickers.
 
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Brand NameBD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
Type of DeviceSYSTEM, BLOOD CULTURING
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13114490
MDR Text Key288185268
Report Number1119779-2021-02060
Device Sequence Number1
Product Code MDB
UDI-Device Identifier30382902451229
UDI-Public30382902451229
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K974883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number245122
Device Catalogue Number245122
Device Lot Number1191962
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2021
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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