BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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Catalog Number 383083 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2022 |
Event Type
malfunction
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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 1271614.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 the bd intima-ii¿ closed iv catheter system tubing clamp was defective and couldn't be tightened during use.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted to hospital on the evening of (b)(6) 2022.Due to acute pharyngitis.The nurse used closed indwelling intravenous needle for infusion, and found that the indwelling needle clamp could not be tightened, so the indwelling needle was replaced immediately.".
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Search Alerts/Recalls
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