BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II¿ IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER
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Catalog Number 383019 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that the tip and middle section of the bd intima ii¿ iv catheter prn adapter needle were defective.The following information was provided by the initial reporter, translated from (b)(6) : "on (b)(6) 2022, when the patient was preparing for infusion, the defect of the tip and the middle part of the needle was found.The closed venous indwelling needle was replaced immediately, and the adverse event monitoring team was reported in a timely manner.If not timely, it could cause serious harm to the patient.".
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 1260564.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.H3 other text : see h10.
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Event Description
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It was reported that the tip and middle section of the bd intima ii¿ iv catheter prn adapter needle were defective.The following information was provided by the initial reporter, translated from chinese: "on march 1, 2022, when the patient was preparing for infusion, the defect of the tip and the middle part of the needle was found.The closed venous indwelling needle was replaced immediately, and the adverse event monitoring team was reported in a timely manner.If not timely, it could cause serious harm to the patient.".
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Search Alerts/Recalls
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