BECTON, DICKINSON & CO. (SPARKS) BD BACTEC FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING
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Model Number 441385 |
Device Problem
Device Ingredient or Reagent Problem (2910)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2021 |
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 bactec¿ fx, instrument top, packaged false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
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Event Description
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It was reported that while using bd bactec¿ fx, instrument top, packaged false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
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Manufacturer Narrative
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H6: investigation summary: customer reported additional bottles have been reported false positive issue during sterility testing on a bd bactec fx top instrument (p/n 441385, s/n (b)(6)).A field service engineer (fse) was dispatched and discovered rack issue.The fse installed shorting pcb assembly (pn# 444876) and cleaned up rack screw threads with a tap.The instrument was deemed functional and handed over to the customer for use.This is a confirmed failure of the bd product.Review of the device history record is not required due to the age of the instrument.Service history record review revealed no previous complaints for this issue.Bd quality did not receive any returned parts or instrument for investigation.The root cause was rack issue.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this failure.H3 other text : see h10.
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Search Alerts/Recalls
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