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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING
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LEE LABORATORIES, INC. BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING Back to Search Results
Catalog Number 245124
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2023
Event Type  malfunction  
Event Description
It was reported that while using bd bactec¿ mgit¿ 960 supplement kit, there was fungal contamination seen on 10 kits.No patient impact reported.
 
Manufacturer Narrative
E.1.Initial reporter first name: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
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Brand Name
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Type of Device
SYSTEM, BLOOD CULTURING
Manufacturer (Section D)
LEE LABORATORIES, INC.
1475 athens highway
grayson GA 30017
Manufacturer (Section G)
LEE LABORATORIES, INC.
1475 athens highway
grayson GA 30017
Manufacturer Contact
jo doyka
7 loveton circle
sparks, MD 21152
4103164000
MDR Report Key18314948
MDR Text Key330943010
Report Number1025402-2023-00046
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382902451242
UDI-Public(01)00382902451242
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K974883
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
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/05/2024
Device Catalogue Number245124
Device Lot Number2188242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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