Catalog Number 383019 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
Skin Inflammation (2443)
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Event Date 10/14/2020 |
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: after the patient was admitted on the (b)(6), the patient was given intravenous implantation of a closed intravenous indwelling needle at 12:00 noon to facilitate infusion.About 15 minutes after the implantation, the patient's arm puncture site appeared redness and swelling.The indwelling needle was removed according to the doctor's advice and the patient was observed.After about 20 minutes, the patient's symptoms improved.
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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.
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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: after the patient was admitted on the 14th, the patient was given intravenous implantation of a closed intravenous indwelling needle at 12:00 noon to facilitate infusion.About 15 minutes after the implantation, the patient's arm puncture site appeared redness and swelling.The indwelling needle was removed according to the doctor's advice and the patient was observed.After about 20 minutes, the patient's symptoms improved.
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Search Alerts/Recalls
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