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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLISON MEDICAL, INC. SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE SYRINGE, PISTON

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ALLISON MEDICAL, INC. SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE SYRINGE, PISTON Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Device Fell (4014)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/11/2021
Event Type  malfunction  
Event Description
[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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Brand NameSAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ALLISON MEDICAL, INC.
MDR Report Key11663735
MDR Text Key245517188
Report NumberMW5100743
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/12/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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