Catalog Number 383911 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 was reported while using bd pegasus yel 24ga x 0.75in prn the needle could not be disengaged.There was no report of patient impact.The puncture was successful when the indwelling needle was injected, the blood returned.When the needle core was ready to be pulled out, it was found that it could not be pulled out.After several unsuccessful attempts, he had to pull it out and start again.
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Manufacturer Narrative
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H6: investigation summary a device history review was conducted for lot number 2140902.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.H3 other text : see h10.
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Event Description
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It was reported while using bd pegasus yel 24ga x 0.75in prn the needle could not be disengaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the puncture was successful when the indwelling needle was injected, the blood returned.When the needle core was ready to be pulled out, it was found that it could not be pulled out.After several unsuccessful attempts, he had to pull it out and start again.
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Search Alerts/Recalls
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