BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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Catalog Number 383033 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: in response to the event reported, a device history review was conducted for lot number 0294804.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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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked during the infusion.The following information was provided by the initial reporter, translated from (b)(6) to english: "at 11:30 a.M., the nurse prepared the patient for infusion.When exhausting, she found that the prn junction of the indwelling needle was leaking, which was in danger of causing infusion reaction, so she replaced the indwelling needle in time.".
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