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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD AIOU RETRACTABLE NEEDLE SAFETY SYRINGE 23G X 1"; SYRINGE, ANTISTICK
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GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD AIOU RETRACTABLE NEEDLE SAFETY SYRINGE 23G X 1"; SYRINGE, ANTISTICK Back to Search Results
Lot Number 20JC2
Device Problems Break (1069); Fluid/Blood Leak (1250); Component Missing (2306); Device Dislodged or Dislocated (2923); Protective Measures Problem (3015); Inaccurate Information (4051)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2021
Event Type  malfunction  
Event Description
Aiou needle retractable safety syringe with needle 23g x 1" lot 20jc2 manufacture date 10/18/2020 expiration date 10/17/2025.Multiple issues: receiving needles with tips broken off, receiving syringes that are unable to be drawn (safety device already engaged therefore not useable), receiving syringes with plunger already drawn back and broken off, non luer lock needle dislodging from the syringe while in use; leading to leakage of vaccine and remaining in patient arm after vaccine administered), black rubber stopper on plunger not straight which is not able to be used as dose would be inaccurate, occasional safety device not engaging which does not allow needle to be withdrawn and protect healthcare personnel from possible sharps injury as designed and lastly receiving missing needles.Fda safety report id # (b)(4).
 
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Brand Name
AIOU RETRACTABLE NEEDLE SAFETY SYRINGE 23G X 1"
Type of Device
SYRINGE, ANTISTICK
Manufacturer (Section D)
GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
MDR Report Key11541059
MDR Text Key241754464
Report NumberMW5100142
Device Sequence Number1
Product Code MEG
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number20JC2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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