BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING
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Model Number 245122 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2022 |
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 has been reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml has been found broken.The following has been provided by the initial reporter: it was reported by the customer that instrument alerted that tube was positive, and when customer went to remove it, the tube was broken.
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Event Description
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It has been reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml has been found broken.The following has been provided by the initial reporter: it was reported by the customer that instrument alerted that tube was positive, and when customer went to remove it, the tube was broken.
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Manufacturer Narrative
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H6: 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 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 four other complaints have been taken on this batch for broken tubes.All four other complaints were not confirmed.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.H3 other text : see h10.
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