MAUDE Adverse Event Report: HAIOU MEDICAL DEVICES / GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD HAIOU NEEDLE RETRACTABLE SAFETY SYRINGE; SYRINGE, ANTISTICK

Device Problems Disconnection (1171); Retraction Problem (1536); Obstruction of Flow (2423); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Event Description

Pfizer-biontech covid-19 vaccine treatment under emergency use authorization (eua): emergency use authorization (eua) of the pfizer-biontech covid-19 vaccine to prevent coronavirus disease 2019 (covid-19) we at the fema vaccination site at the (b)(6) center have encountered multiple problems with the haiou needle safety retractable syringe leading issues involving patient safety, vaccinator safety, and wasted doses.It is important to note that this is a needle/syringe device that comes pre-assembled and is not assembled by any of our personnel.Please see below regarding the issues and included pictures.Problems: the needle has come dislodged from the syringe and hub when being uncapped by a vaccinator.This is a near miss as it was seconds away from being administered to a patient and could have been lodged in their arm.Also lead to wasted dose; the needle and hub came disconnected from the syringe during vaccine administration getting stuck in multiple patient's arms requiring manual removal.This occurred 3 times during only 600 uses.This lead to 2 incidents of not all vaccine being administered of unknown amount and requiring re-vaccination in the other arm.Thus, 2 wasted doses; after administration, vaccinator with plenty of experience with this needle went to retract needle into syringe, but the needle was disconnected from the plunger leading a vaccinator safety issue.This occurred 5 times with a span of 500 uses of this product; multiple bent needles leading to 4 wasted doses in span of 400 vaccines; 4 instances where the needle was clogged with uncertain debris.Syringe plunger was pulled back, but would then go back to its original position on its own seemingly in a vacuum state.To further prove the needle was clogged, we tried withdrawing normal saline into syringe without ability to do so (we have video proof of this); on some syringes, the top of the plunger, which is crucial for measuring the dose, is slanted leading to inaccurate doses.Fda safety report id# (b)(4).

• Brand Name: HAIOU NEEDLE RETRACTABLE SAFETY SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): HAIOU MEDICAL DEVICES / GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
• MDR Report Key: 11581073
• MDR Text Key: 242990326
• Report Number: MW5100306
• Device Sequence Number: 8
• 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: Physician
• Type of Report: Initial
• Report Date: 03/25/2021
• 17 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1