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 07/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml a broken bottle was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter, it was reported that broken tube.
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Event Description
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It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml a broken bottle was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter " it was reported that broken tube.".
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Manufacturer Narrative
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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 1078377 was satisfactory per internal procedures.Formulation, filling, and packaging 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.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and three other complaints have been taken on this batch for broken tubes.Retention samples from batch 1078377 (100 tubes) were available for inspection.No tube defects were observed in 100/100 retention samples.No broken tubes were observed in 100/100 retention tubes.No photos were received to assist with the investigation.No returns were received to assist with the investigation.The complaint cannot be confirmed.Bd will continue to trend complaints for broken tubes.Bd ships product in temperature controlled trucks to distribution centers.Distribution centers are provided with shipping and storage guidelines.Mishandling of the product and vibrations during shipping can cause broken tubes.
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