Catalog Number 383912 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd pegasus yel 24ga x 0.75in prn-cap y the needle did not properly disengage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: for treatment needs, indwelling needles were used for patients.During use, it was found that the needle core of the indwelling needles could not be separated, so the needles were pulled out and replaced again, comforting the patients, and doing a good job of explaining.
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Manufacturer Narrative
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H.3.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 while using bd pegasus yel 24ga x 0.75in prn-cap y the needle did not properly disengage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: for treatment needs, indwelling needles were used for patients.During use, it was found that the needle core of the indwelling needles could not be separated, so the needles were pulled out and replaced again, comforting the patients, and doing a good job of explaining.
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 3108288.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Search Alerts/Recalls
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