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

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).

• Brand Name: SAFETY FIRST LUER LOCK 1 ML 23 GAUGE/1 INCH SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ALLISON MEDICAL, INC.
• MDR Report Key: 11663735
• MDR Text Key: 245517188
• Report Number: MW5100743
• Device Sequence Number: 2
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1