BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED; SYSTEM, BLOOD CULTURING
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Model Number 441386 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that bd bactec¿ fx, instrument bottom, packaged has worn feet.No patient impact.The following information was provided by the initial reporter: while conducting annual pm, was unable to adjust feet properly due to wear on adjustment nut.
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Manufacturer Narrative
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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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Manufacturer Narrative
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H6: investigation summary a complaint of "worn feet" was received against instrument bottom bactec fx packaged material number: 441386, serial number: (b)(6).A bd remote assistance associate communicated with the customer and the customer was not responded and no further action was taken as part of this complaint.Instrument was found to be functional, and the customer started using the instrument for regular operation.This is an unconfirmed complaint, and the root cause was unable to be determined.Dhr review for the instrument (b)(6), is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review revealed no previous complaints for this issue.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could 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.H3 other text : see h10.
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Event Description
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It was reported that bd bactec¿ fx, instrument bottom, packaged has worn feet.No patient impact.The following information was provided by the initial reporter: while conducting annual pm, was unable to adjust feet properly due to wear on adjustment nut.
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