BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
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Model Number 231727 |
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 01/10/2023 |
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 60 bd bbl¿ taxo¿ differentiation discs for v factor during validation no growth occurred.The following information was provided by the initial reporter: no growth of haemophilus influenzae at the edge of 60 disc with the use of a cos + factor v medium during validation no growth , are testing now with other batch , tomorrow noon 11/1/23 12h i have to call the customer for results other batch.
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Event Description
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It was reported that 60 bd bbl¿ taxo¿ differentiation discs for v factor during validation no growth occurred.The following information was provided by the initial reporter: no growth of haemophilus influenzae at the edge of 60 disc with the use of a cos + factor v medium during validation no growth , are testing now with other batch , tomorrow noon 11/1/2023 12h i have to call the customer for results other batch.
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Manufacturer Narrative
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H6 investigation summary: a complaint investigation due to no growth for taxo v factors catalog 231727 batch no.: 6924935 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, visual inspection, and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
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Search Alerts/Recalls
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