Model Number 231319 |
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 06/07/2021 |
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 while using bd bbl¿ sensi-disc¿ oxacillin - 1 g atypical growth was observed by the laboratory personnel.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: "the customer would like to complain about batch: 0121991 of oxacillin 1 g cartridges.The oxacillin is resistant to streptococcus pneumoniae atcc 49619.Customer had another batch (0092546) there and this is sensitive.".
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Manufacturer Narrative
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H6: investigation summary: a complaint investigation for oxacillin batch no.: 0121991 was performed on retention samples.Returned goods were not received from customer.The investigation required to perform bauer kirby test, visual inspection, and batch record review.Retention samples performed as expected.Refer to results below.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Photo received was evaluated.Customer claim could not be confirmed through photo evaluation.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.H3 other text : see h10.
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Event Description
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It was reported that while using bd bbl¿ sensi-disc¿ oxacillin - 1 g atypical growth was observed by the laboratory personnel.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: "the customer would like to complain about batch: 0121991 of oxacillin 1g cartridges.The oxacillin is resistant to streptococcus pneumoniae atcc 49619.[customer] had another batch (0092546) there and this is sensitive.".
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Search Alerts/Recalls
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