TRIPATH IMAGING, INC BD TOTALYS SLIDEPREP; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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Catalog Number 491346 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2023 |
Event Type
malfunction
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Event Description
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It was reported when using the bd totalys slideprep, a semicircular contaminated trajectory formed on one (1) specimen.There was no report of patient impact.
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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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Manufacturer Narrative
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Investigation summary: a complaint of "a semicircular trajectory is formed on the specimen" was received against totals slideprep ce material number: 491346, serial number: (b)(6).Field service engineer (fse) investigated and concluded that there is no problem with the instrument and the instrument is working smoothly.This complaint is not a confirmed failure of the instrument.Device history record review for the instrument ppla300234 is not required for this complaint as this complaint does not allege an early life failure or failure at installation.Service history review was performed for the instrument ppla300234, and no additional work orders were observed for the complaint failure mode reported.Samples were not received by quality for investigation and thus, returned material investigation could not occur.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 complaint.
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Event Description
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It was reported when using the bd totally slideprep, a semicircular contaminated trajectory formed on one (1) specimen.There was no report of patient impact.
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Search Alerts/Recalls
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