BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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Catalog Number 383078 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2021 |
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 0063939.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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.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 black foreign matter was found on the bd intima-ii¿ closed iv catheter system's prn after opening the packaging.The following information was provided by the initial reporter, translated from (b)(6): "the patient needed antibiotic treatment for acute diarrhea, and was prepared for venipuncture with indwelling needle on march 12.After the outer package of the indwelling needle was open, black spots were found on the prn of the indwelling needle, which might cause infection to the patient.The indwelling needle was replaced and venipuncture was performed".
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