MAUDE Adverse Event Report: GUANGDONG, NANYUAN INDUSTRIAL ZONE CN / GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD AIOU NEEDLE RETRACTABLE SAFETY SYRINGE; SYRINGE, ANTISTICK

Lot Number 20IB0

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2021

Event Type  malfunction  

Event Description

Syringe failures.Multiple syringes do not allow withdrawing of dose from covid vaccine vial.This particular syringe from aiou brand needle retractable safety syringe with needle 1ml 25g 1 inch separated during hun from needle while injecting patient causing dose to spray out from syringe tip rather than injecting into patient.Lot 20ib0 received in covid vaccine supply kit from mckesson.Fda safety report id # (b)(4).

• Brand Name: AIOU NEEDLE RETRACTABLE SAFETY SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG, NANYUAN INDUSTRIAL ZONE CN / GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
• MDR Report Key: 11377808
• MDR Text Key: 233743040
• Report Number: MW5099607
• Device Sequence Number: 1
• Product Code: MEG
• 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: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20IB0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 68