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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
Model Number 245124
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Event Description
It was reported that analyzing the bd bactec¿ mgit¿ 960 supplement kit, biological contamination was observed. There were no results reported to physicians and there was no patient impact. The following information was provided by the initial reporter: customer complained detective additive of mgit supplement defective (foreign matter).
 
Manufacturer Narrative
Mgit 960 supplement kit batch 1271214 is composed of mgit panta batch 1266134 and mgit 960 growth supplement batch 1260725. The batch history record review for mgit 960 supplement kit batch 1271214 was satisfactory. No quality notifications were generated during manufacturing and no other complaints have been taken on this kit batch. Mgit panta is manufactured by rehydrating components in usp purified water and mixed into a homogenous solution. The solution is then sterile filtered, dispensed into vials and stoppered by machine. The vials are lyophilized, and crimp caps are applied per standard operating procedures (sop). Mgit 960 growth supplement is manufactured by rehydrating the media components with usp purified water and mixed until a homogeneous solution is obtained. The solution is then sterile filtered and dispensed into vials; stoppers are manually placed in the vial opening; septum caps are manually placed on top of the stopper and then mechanically crimped per sop. Six mgit panta vials are then manually packaged with six mgit growth supplement vials to make a mgit 960 supplement kit (material 245124). The batch history record reviews for mgit panta batch 1266134 was satisfactory per internal procedures and mgit 960 growth supplement batch 1260725 was satisfactory per internal procedures. Qc inspection and testing were satisfactory at time of release. Retentions for panta batch 1266134 (6 vials) and growth supplement batch 1260725 (2 vials) were available for inspection. All retention vials maintained had no evidence of contamination from visual inspection. For investigation, two retention panta vials batch 1266134 were reconstituted (per procedure) with two growth supplement vials from batch 1260725. One reconstituted panta vial and remaining growth supplement were incubated at 33-35-degrees celsius; and one reconstituted panta and remaining supplement vial were incubated at 20-25-degree celsius. At the end of a seven-day incubation period no microbial growth was observed in 4/4 retention vials. Three photos were received to assist with the investigation: the first photo shows a closed kit carton from kit batch 1271214. A reconstituted panta vial is on top of the kit carton. The panta vial is parafilm around the stopper the vial appears to be uncrimped. There does appear to be fungal growth in the vial. The second photo shows a partial closed kit carton from kit batch 1271214. There is a partial reconstituted panta vial from batch 1266134. There does appear to be fungal growth in the vial. The last photo shows an opened kit carton. Two supplement vials are still crimp capped sealed in the packaging insert. One reconstituted panta from batch 1266134 is sitting on top of the packaging insert. The reconstituted panta vial is wrapped in parafilm. There does appear to be fungal growth in the vial. No returns were received to assist with the investigation. The complaint can be confirmed based on the evidence provided by the photos. Bd will continue to trend complaints for contamination.
 
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Brand NameBD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Type of DeviceSYSTEM, 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15222131
MDR Text Key302805971
Report Number1025402-2022-00006
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382902451242
UDI-Public00382902451242
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K974883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number245124
Device Catalogue Number245124
Device Lot Number1271214
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2021
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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