Catalog Number 254081 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd plate mueller hinton ii agar 90mm, the device experienced contamination - biological contamination - bacterial, fungal, non-viable.The following information was provided by the initial reporter.The customer stated: the plates arrived contaminated with mold.
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Manufacturer Narrative
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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 it was reported that half of the plates would be contaminated.Complaint history review: the complaints trends were reviewed for a period and no similar complaints received during that period on this lot number.Therefore, a trend could not be identified.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.Sample analysis: the retain samples were reviewed and no deviation could be detected.Picture sample documenting the reported contamination was provided.As per the pictures contaminated plates were shown.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9%.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high quality standard, we only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Investigation conclusion: based on the evaluation and the provided pictures, the complaint was confirmed for contamination.H3 other text : see h10.
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Event Description
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It was reported when using the bd plate mueller hinton ii agar 90mm, the device experienced contamination - biological contamination - bacterial, fungal, non-viable.The following information was provided by the initial reporter.The customer stated: the plates arrived contaminated with mold.
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Search Alerts/Recalls
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