Catalog Number 383019 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Inflammation (2443)
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Event Date 10/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that bd intima-ii closed iv catheter system was used on the patient and a reaction occurred.The following information was provided by the initial reporter: the patient was given an arm puncture with a closed intravenous indwelling needle at 8:00 a.M.On the 16th, which was used for respiratory infection to facilitate infusion.About 10 minutes after the implantation, the patient's arm was redness and swelling.The indwelling needle was immediately pulled out for observation as instructed by the doctor, and the patient's symptoms improved after 15 minutes.
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Manufacturer Narrative
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H6 investigation: a device history review was conducted for lot number 9347648.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.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.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 bd intima-ii¿ closed iv catheter system was used on the patient and a reaction occurred.The following information was provided by the initial reporter: the patient was given an arm puncture with a closed intravenous indwelling needle at 8:00 a.M.On the (b)(6), which was used for respiratory infection to facilitate infusion.About 10 minutes after the implantation, the patient's arm was redness and swelling.The indwelling needle was immediately pulled out for observation as instructed by the doctor, and the patient's symptoms improved after 15 minutes.
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Search Alerts/Recalls
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