MAUDE Adverse Event Report: GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD AIOU NEEDLE RETRACTABLE SAFETY SYRINGE WITH NEEDLE 23GX1"; SYRINGE, ANTISTICK

Lot Number 20JC2

Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  malfunction  

Event Description

Syringe broke apart while covid-19 vaccine was being administered.Needle and hub separated during vaccine administration and vaccinator and patient were sprayed with vaccine.Needle and hub remained in patient's arm despite no longer being attached to syringe.Vaccinator carefully removed needle and hub from patient's arm and disposed of it in sharps container.Syringe type: aiou needle retractable safety syringe with needle 23gx1" lot 20jc2.Fda safety report id# (b)(4).

• Brand Name: AIOU NEEDLE RETRACTABLE SAFETY SYRINGE WITH NEEDLE 23GX1"
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
• MDR Report Key: 11574212
• MDR Text Key: 242752507
• Report Number: MW5100266
• Device Sequence Number: 1
• Product Code: MEG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/23/2021

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: No Information
• Device Lot Number: 20JC2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1