Catalog Number 257306 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.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 while testing with bd columbia cna agar with 5% sheep blood biological contamination was observed.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: plates are contaminated.
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Manufacturer Narrative
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H.6 investigation summary: event description: it was reported plates being affected by contamination.Complaint history review: the complaint trends were reviewed and similar complaints were found for this catalog number.This issue will be investigated within a capa (corrective and preventive action).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: retain samples were analyzed.No contamination was detected after incubation of the plates.Neither return samples nor pictures illustrating the issue were shared.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.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 a contaminated plate.The review of the batch history did no indicate any discrepancy.Investigation conclusion: although no picture illustrating this issue was shared, the complaint can be confirmed based on the trend; a capa was initiated.Bd will continue to monitor incoming complaint for this issue h3 other text : see h.10.
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Event Description
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It was reported while testing with bd columbia cna agar with 5% sheep blood biological contamination was observed.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: plates are contaminated.
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Search Alerts/Recalls
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