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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 Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
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 when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, the tube cracked and patient sample leaked.The following information was provided by the initial reporter.The customer stated: when unloaded as a completed negative vial, it was noticed that ~6ml liquid was missing from the tube.Inspection revealed a crack in the tube.They have discarded the tube immediately due to health and safety risks, so unable to provide a photo.They did not perform a stain on the remaining liquid to confirm if there are organisms present.Sample was negative on the instrument, but an additional sample was positive, so it is assumed it is a false negative due to the crack/lost liquid.
 
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 1300510 was satisfactory per internal procedures.Filling and packaging processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures and checks for torque confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and one other complaint have been taken on this batch.Retention samples from batch 1300510 (100 tubes) were available for inspection.No broken/cracked tubes were observed in 100/100 retention samples.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed by the investigation of the retention samples and lack of photos and returns, however manufacturing records indicate that broken tubes were observed due to a mechanical defect during manufacturing.Repairs to the equipment were made and additional inspections were completed on this batch, however this does not guarantee no defects.This complaint is confirmed due to the mechanical defect identified during production of the batch.Bd will continue to trend complaints for broken/cracked tubes.Notes: risk management review indicates the potential risk of the defect reported was assessed as severity [s4], per [baltrmlmbactecmgitaph ], rev [03], id [10.0].H3 other text : see h.10.
 
Event Description
It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, the tube cracked and patient sample leaked.The following information was provided by the initial reporter.The customer stated: when unloaded as a completed negative vial, it was noticed that ~6ml liquid was missing from the tube.Inspection revealed a crack in the tube.They have discarded the tube immediately due to health and safety risks, so unable to provide a photo.They did not perform a stain on the remaining liquid to confirm if there are organisms present.Sample was negative on the instrument, but an additional sample was positive, so it is assumed it is a false negative due to the crack/lost liquid.
 
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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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14973731
MDR Text Key304511085
Report Number1119779-2022-00977
Device Sequence Number1
Product Code MDB
UDI-Device Identifier30382902451229
UDI-Public30382902451229
Combination Product (y/n)N
Reporter Country CodeUK
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 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/23/2023
Device Model Number245122
Device Catalogue Number245122
Device Lot Number1300510
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2022
Initial Date FDA Received07/10/2022
Supplement Dates Manufacturer Received08/29/2022
Supplement Dates FDA Received09/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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