BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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Catalog Number 383080 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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In response to the event reported, a device history review was conducted for lot number 1051555.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.
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Event Description
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It was reported that medication leaked from the bd intima-ii¿ closed iv catheter system connection to the heparin cap.The following information was provided by the initial reporter, translated from chinese: "before intravenous indwelling needle infusion was given to the patient, a 5 ml syringe was connected to drain the fluid, and fluid leakage was found at the junction of the heparin cap, which should be replaced in time to prevent adverse reactions".
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Search Alerts/Recalls
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