BECTON, DICKINSON & CO. (SPARKS) BD PREPSTAIN¿; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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Model Number 490100 |
Device Problem
Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
Event Type
malfunction
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Event Description
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It has been reported that the bd prepstain¿ has been found experiencing lid issues.The following has been provided by the initial reporter: tripath us ii - centrifuge lid unsupported.
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Manufacturer Narrative
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Medical device expiration date: na.Initial reporter phone#: (b)(6).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 has been reported that the bd pepstatin¿ has been found experiencing lid issues.The following has been provided by the initial reporter: tripath us ii - centrifuge lid unsupported.
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Manufacturer Narrative
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H.6.Investigation: complaint reports lid failure on centrifuge associated with prepstain (catalog number 490100) serial number (b)(6).Complaint alleges centrifuge hydraulic rod failure, no support for the lid to stay open.Customer was informed no spare hydraulic rods are available, recommend replacing the centrifuge.Customer advised that the issue does not affect the normal function of the centrifuge and will continue to use.Post intervention the instrument was left operating normally.Root cause is not determined, and this complaint is not a confirmed failure of the instrument based on the customer response.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 (b)(6)2017.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 "centrifuge.".
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