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

Device Problems Fluid/Blood Leak (1250); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Description

Syringes shipped in covid-19 vaccine supply packs from federal gov't i am reporting quality issues with 1 ml syringes with 1 inch needles manufactured by guangdong haiou medical apparatus co.The following problems have been observed during mass vaccination clinic this week: leaking between the needle and syringe hub; needle hub floating back into syringe barrel when needle inserted into vial; needle shooting out of the syringe when plunger pressed into hub after administration.(b)(4).

• Brand Name: SYRINGE NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD.
• MDR Report Key: 12843820
• MDR Text Key: 281110896
• Report Number: MW5105456
• Device Sequence Number: 3
• Product Code: MEG
• Combination Product (y/n): N
• 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
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1