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

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2021

Event Type  malfunction  

Event Description

Brand aiou 1ml syringes needle retractable safety syringes with needle.26 g x 1" 1639/iso 13485 - supplied with covid-19 pfizer vaccine.Needle separated from the barrel remaining in the patient's arm- causing loss of vaccine.Patients needed to be revaccinated.Occurred 6 times in one day at a mega site vaccination center.Unable to identify exact lot numbers as syringes were opened in advance.No immediate harm to patients.Fda safety report id# (b)(4).

• Brand Name: AIOU SAFETY SYRINGES WITH NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
• MDR Report Key: 11404081
• MDR Text Key: 234638480
• Report Number: MW5099726
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1