BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
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Catalog Number 297354 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 while using bd bbl¿ trypticase¿ soy broth that there was no growth.The following information was provided by the initial reporter: 3 organisms were not growing (in-house isolate: m.Luteus , ez-accushot: s.Aureus and g.Stearothermophilus) in tsb but was growing well on the tsa inoculation verification.It was her second attempt using the ez-accushot and first attempt using the in-house isolate, yielding no growth.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-01015 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
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Event Description
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It was reported that while using bd bbl¿ trypticase¿ soy broth that there was no growth.The following information was provided by the initial reporter: 3 organisms were not growing (in-house isolate: m.Luteus , ez-accushot: s.Aureus and g.Stearothermophilus) in tsb but was growing well on the tsa inoculation verification.It was her second attempt using the ez-accushot and first attempt using the in-house isolate, yielding no growth.
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