BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING
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Model Number 441385 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.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 the bd bactec¿ fx, instrument top, packaged moves every time drawer is opened.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: every time you open the drawer, the jp stand will shift, so please take measures to prevent it from shifting.
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Manufacturer Narrative
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Medical device expiration date: na.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 the bd bactec¿ fx, instrument top, packaged moves every time drawer is opened.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: every time you open the drawer, the jp stand will shift, so please take measures to prevent it from shifting.
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Manufacturer Narrative
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H.6 investigation: a complaint of "jp stand is shifting when opening the drawer" was received against instrument top bactec fx packaged material number: 441385, serial number: (b)(6).A bd field service engineer (fse) was dispatched and installed a board behind the instrument, thus the issue was resolved.The complaint is unconfirmed failure of the bd product because the issue was not due to instrument/part failure.The root cause was unable to be determined with the provided information.Dhr review is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.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.
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Event Description
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It was reported that the bd bactec¿ fx, instrument top, packaged moves every time drawer is opened.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: every time you open the drawer, the jp stand will shift, so please take measures to prevent it from shifting.
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