BECTON, DICKINSON & CO. (SPARKS) BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
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Catalog Number 251176 |
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 11/11/2022 |
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 was reported that bbl - mueller hinton agar with 5% sheep blood contamination occurred.That following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, the media was found to be contaminated before usage.The facility has experienced contamination from their refrigerator, so the regirigerator may be the cause.
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Manufacturer Narrative
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H.6 investigation summary: 251176 #2228472 we couldn't confirm as a report because no photo and returned sample.Complaint history was reviewed, and no other complaint has been taken on this lot.At this time.Did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.It includes bioburden testing.A visual inspection was performed on 20 retention samples of this lot.As a result, no contamination was observed.The root cause for this could not be determined.We will continue to monitor this lot.
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Event Description
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It was reported that bbl - mueller hinton agar with 5% sheep blood contamination occurred.That following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, the media was found to be contaminated before usage.The facility has experienced contamination from their refrigerator, so the refrigerator may be the cause.
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Search Alerts/Recalls
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