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

Model Number CE 1639

Device Problems Disconnection (1171); Retraction Problem (1536); Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

Covid pfizer treatment under emergency use authorization(eua): on (b)(6) 2021 (b)(6) region team were at (b)(6) giving pfizer vaccines in an outreach event.Some of the needles sent to our team from pfizer to vaccinate were from the guangdong haiou medical apparatus co.Ltd they are a needle retractable safety syringe.Our team lost 1 vaccine because when the vaccine was administered into the clients arm the syringe disconnected from the needle and the vaccine was lost.The client had to be revaccinated.When the team drawing up the vaccines were pulling back the syringe to draw up the vaccine 12 of the syringes came apart and the plunger just came out of the end of the syringe.Nurses who were vaccinating also reported that many of the needles would not properly retract.Our team was able to replace the remaining needles and syringes with needles and syringes we had at our local public health office and we removed the remaining products from the event and have them at our pho and will not use them.That is (b)(6).Fda safety report id# (b)(4).

• Brand Name: HAIOU NEEDLE RETRACTABLE SAFETY SYRINGE WITH NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD.
• MDR Report Key: 11633422
• MDR Text Key: 244663959
• Report Number: MW5100619
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/05/2021
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE 1639
• Device Catalogue Number: ISO 13485
• Device Lot Number: 20JC2
• Was Device Available for Evaluation?: Yes
• 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