Catalog Number 251239 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that 23 bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) plates were found with bacterial contamination before use.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about contamination of the media.According to the customer's report, bacterial growth was found in 23 plates in the complaint lot before usage.".
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, the bd ds headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.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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H6.Investigation summary: bd confirmed this issue as a reported defect on a returned sample.A visual inspection was performed on 20 retention samples of this lot.As a result, no contamination was observed.The issue was confirmed as contamination.Bd quality will continue to monitor this issue.
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Event Description
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It was reported that 23 bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) plates were found with bacterial contamination before use.The following information was provided by the initial reporter, translated from japanese: "this is a report about contamination of the media.According to the customer's report, bacterial growth was found in 23 plates in the complaint lot before usage.".
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Search Alerts/Recalls
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