BECTON, DICKINSON & CO. (SPARKS) BD PREPSTAIN¿; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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Catalog Number 490100 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that during use with the bd prepstain¿, a patient thyroid sample was contaminated with vaginal cells.There was no report of patient impact.
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Event Description
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It was reported that during use with the bd prepstain¿, a patient thyroid sample was contaminated with vaginal cells.There was no report of patient impact.
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Manufacturer Narrative
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Investigation summary complaint reports contamination on prepstain (catalog number 490100) serial number (b)(6).Complaint alleges non-gynecological slide showing cellularity of gynecological sample.Customer stated no erroneous results reported.Service assist remotely through phone call and educate customer on the importance of cleaning the aspiration pump and correct pressure of the aspiration pump.Root cause attributed to the delivery of vials exchanged by the patient (who had two vials of different samples) to the technical team.This complaint is not a confirmed failure of the instrument based on the service investigation.Review of device history record for instrument serial number, (b)(6)is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on 7/20/2018.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "contamination / foreign matter.".
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Search Alerts/Recalls
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