Catalog Number 383717 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).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 needle was difficult to remove while using bd pegasus¿ safety closed iv catheter.No patient impact was reported.The following information was provided by the initial reporter, translated from chinese to english: the head nurse of gastroenterology department reported that it was difficult to remove the indwelling needle core during use.
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Event Description
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It was reported that the needle was difficult to remove while using bd pegasus¿ safety closed iv catheter.No patient impact was reported.The following information was provided by the initial reporter, translated from chinese to english: the head nurse of gastroenterology department reported that it was difficult to remove the indwelling needle core during use.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 1320190.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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