MAUDE Adverse Event Report: GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD HAIOU NEEDLE RETRACTABLE SAFETY SYRINGE 23G 1"; SYRINGE, ANTISTICK

Model Number ISO13485

Device Problems Entrapment of Device (1212); Separation Problem (4043)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2021

Event Type  Injury  

Event Description

[haiou syringes] treatment under emergency use authorization(eua): needle malfunction.Retractable haiou brand needle supplied with covid supply packs.Needle separated from syringe and plunder and remained in patient arm after injection.Fda safety report id# (b)(4).

• Brand Name: HAIOU NEEDLE RETRACTABLE SAFETY SYRINGE 23G 1"
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
• MDR Report Key: 11595125
• MDR Text Key: 243557670
• Report Number: MW5100402
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ISO13485
• Device Catalogue Number: 20201018:20251017
• Device Lot Number: 20JC2
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR