Catalog Number UNKNOWN |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
Injury
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Event Description
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It was reported that while using unspecified bd bactec¿ plus aerobic culture vials (plastic), seven bottles cultured from one patient were contaminated with exophiala dermatitidis.Patient was treated based on erroneous results as it was not entirely clear the result was erroneous.No medical intervention or adverse effect reported from treatment change.
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Manufacturer Narrative
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H3.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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Manufacturer Narrative
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H.6.Investigation summary: customer reported a contamination issue.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.Complaint is unconfirmed.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h.10.
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Event Description
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It was reported that while using unspecified bd bactec¿ plus aerobic culture vials (plastic), seven bottles cultured from one patient were contaminated with exophiala dermatitidis.Patient was treated based on erroneous results as it was not entirely clear the result was erroneous.No medical intervention or adverse effect reported from treatment change.
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Search Alerts/Recalls
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