BAIN MEDICAL EQUIPMENT (GUANGZHU), NO. 10, JUNCHEN BAIN FISTULA NEEDLE 15GX1, FIXED; NEEDLE, FISTULA
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Model Number 09-09SG-0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Type
Injury
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Event Description
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A user facility clinical manager reported via fax that the fistula needle causes bleeding around needle sites during treatment.They were able to stop bleeding after using clothing, band aids and gauze.C-621287 (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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