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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
Catalog Number 245122
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  malfunction  
Event Description
It was reported that while using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml that there is a leaking/broken bactec bottle - containing patient sample.The following information was provided by the initial reporter: loosen of mgit screw cap were found and caused the leakage of media inside.
 
Manufacturer Narrative
E.7 initial reporter addr 1: (b)(6).H.3.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 while using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml that there is a leaking/broken bactec bottle - containing patient sample.The following information was provided by the initial reporter: loosen of mgit screw cap were found and caused the leakage of media inside.
 
Manufacturer Narrative
H.6.Investigation summary: material 245122 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued, and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 2312543 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation and filling processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Checks for fill volume were complete and within specifications per procedures.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed for this batch, and there is no other complaint for loose caps or leaking on this batch.Retentions for batch 2312543 (100 tubes) were available for inspection.No media defects were observed in 100/100 retention samples.No loose caps or low fill volume defects were observed in 100 retention samples.All 100/100 retention samples were measured using a fill volume measuring tool all 100/100 retention tubes measured at the acceptable media fill line.No loose caps were observed in 100/100 retention samples.No leaking tubes were observed in 100/100 retention samples.One photo was received to assist with the investigation: ¿ the photo shows two partial tubes (the caps cannot be observed from the photo).The tube on the left is from batch 2312543 and the tube on the right is from batch 2307815.The media fill in both tubes appear lower than expected.No returns were received for investigation.A loose cap can be an indication of a tube that is low filled because of a tube that leaked, possibly from a tube that may have been leaking due to a loose cap.The complaint can be confirmed for both defects.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for cap defects and leaking.
 
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Brand Name
BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
Type of Device
SYSTEM, 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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17421338
MDR Text Key320227939
Report Number1119779-2023-00814
Device Sequence Number1
Product Code MDB
UDI-Device Identifier30382902451229
UDI-Public30382902451229
Combination Product (y/n)N
Reporter Country CodeTH
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,Followup
Report Date 09/07/2023
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 Date05/05/2024
Device Catalogue Number245122
Device Lot Number2312543
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2023
Initial Date FDA Received07/28/2023
Supplement Dates Manufacturer Received09/07/2023
Supplement Dates FDA Received09/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2022
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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