Catalog Number 383712 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that bd pegasus safety closed iv catheter system had a needle that wasn't able to disengage.The following information was provided by the initial reporter: "the nurse found that the needle could not be withdrawn during the process of withdrawing the needle.".
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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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Manufacturer Narrative
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Follow up mdr for device evaluation.In response to the event reported by your facility a device history review was conducted for lot number 1175356.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.Bd will continue to monitor this issue and encourages you to submit your sample for review.
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Event Description
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No additional information.
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Search Alerts/Recalls
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