BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING
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Model Number 245122 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml experienced bottle damage containing the patient sample.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: broken empty vial flagged positive.Result not provided to provider or posted on patient chart.Customer reporting mgit tube broke within instrument.
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml experienced bottle damage containing the patient sample.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: broken empty vial flagged positive.Result not provided to provider or posted on patient chart.Customer reporting mgit tube broke within instrument.
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-nov-2021.H.6.Investigation: 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 1204331 was satisfactory per internal procedures.Formulation, filling, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and six other complaints have been taken on this batch for broken/cracked tubes only four complaints have been confirmed for broken/cracked tubes.Retention samples from batch 1204331 were available for inspection.No defects were observed in 100/100 retention samples.The retentions were performance tested for growth and susceptibility.All performance testing was satisfactory per procedures.No photos were received to assist with the investigation.Returns were received to assist with the investigation.A shipping box was received with two bd cartons from batch 1204331.There were one-hundred and forty tubes received.Twenty tubes were received broken.Returns were also performance tested for growth and susceptibility.All performance testing was satisfactory per procedure.This complaint can be confirmed for broken tubes based on the returns.This complaint cannot be confirmed for performance.The bd engineering team identified several areas for improvement for the manufacturing of the 245122 bactec mgit 7ml tubes.Improvement projects have been completed.Bd will continue to trend complaints for broken tubes and performance.
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Event Description
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It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml experienced bottle damage containing the patient sample.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: broken empty vial flagged positive.Result not provided to provider or posted on patient chart.Customer reporting mgit tube broke within instrument.
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