BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC; INTRAVASCULAR CATHETER
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Catalog Number 383716 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that while using a bd pegasus yel 24gax0.75in prn-capy non-pvc the needle was difficult to disengage.Patient had to have catheter replaced.The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was given intravenous indwelling needle on (b)(6) 2021, after successful puncture, the steel needle of the indwelling needle could not be removed, so it was immediately replaced and indwelled again.
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Manufacturer Narrative
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Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 1152550.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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