ALLISON MEDICAL, INC. SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE; SYRINGE, PISTON
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Device Problems
Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Device Fell (4014)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/11/2021 |
Event Type
malfunction
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Event Description
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[carepoint safety first luer lock 1 ml 23 gauge/1 inch syringe, ref 35-8204] treatment under emergency use authorization(eua): syringe was being used to deliver janssen covid 19 vaccine and was provided in our ancillary kits for use; 2 times the needle fell off the syringe during vaccine administration despite tightening the leur lock connection prior to use; 1 time the syringe stopper was slanted and wouldn't allow a full dose to be administered.Fda safety report id# (b)(4).
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