Catalog Number 383019 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inflammation (1932)
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Event Date 09/16/2020 |
Event Type
Injury
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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.Fda device problem code: 2993, fda patient problem code: 1932.
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Event Description
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It was reported that the patient developed swelling at the bd intima ii¿ iv catheter prn adapter puncture site during the infusion, which was diagnosed as phlebitis.The needle was removed, local symptomatic treatment was performed, and the patient's symptoms were gone by the following day.The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted for treatment due to "femoral neck fracture".On the fourth day of admission, the nurse noticed redness and swelling at the puncture site during infusion at 9 am.The patient reported local pain, which was diagnosed as phlebitis by the attending physician, the disposable indwelling needle immediately removed with local symptomatic treatment, one day later the symptoms was disappeared".
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Manufacturer Narrative
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Investigation summary a device history review was conducted for lot number 8262024.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, 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 the patient developed swelling at the bd intima ii¿ iv catheter prn adapter puncture site during the infusion, which was diagnosed as phlebitis.The needle was removed, local symptomatic treatment was performed, and the patient's symptoms were gone by the following day.The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted for treatment due to "femoral neck fracture".On the fourth day of admission, the nurse noticed redness and swelling at the puncture site during infusion at 9 am.The patient reported local pain, which was diagnosed as phlebitis by the attending physician, the disposable indwelling needle immediately removed with local symptomatic treatment, one day later the symptoms was disappeared".
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Search Alerts/Recalls
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