BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRATING SYRINGE TYPE CW

    MDR report key: 16763790 · Received April 18, 2023

    Report

    Report Number
    2246990-2023-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 18, 2023
    Manufacturer
    J & J INSTRUMENTS, LLC
    Product Code
    EJI
    UDI-DI
    00304040004456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SYRINGES WERE RETURNED BY THE CUSTOMER FOR EVALUATION. THE EVALUATION DETERMINED THAT THE SYRINGE SHOWED SIGNS OF CROSS THREADING WHERE THE NEEDLE ATTACHES WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE LOT HISTORY RECORD WAS REVIEWED AND CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATION. THE CROSS THREADING MAY HAVE BEEN CAUSED BY MISHANDLING BY USER FACILITY PERSONNEL. ADDITIONALLY, THE EMPLOYEE SHOULD HAVE ENSURED THE NEEDLE WAS CAPPED DURING HANDLING. THE INSTRUCTIONS FOR USE STATE, "WARNING TO AVOID NEEDLE STICKS, RE-CAP NEEDLE AFTER INJECTION HAS BEEN GIVEN. PRECAUTIONS KEEP NEEDLE CAPPED WHILE AFFIXING OR REMOVING FROM SYRINGE."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A DENTAL EXTRACTION PROCEDURE A DENTAL ASSISTANT'S FINGER WAS PRICKED BY A NEEDLE ATTACHED TO THEIR 100-9808 ASPIRATING SYRINGE. THE ASSISTANT DISINFECTED THEIR FINGER, SELF-APPLIED A BANDAGE, AND WAS REFERRED TO VISIT THEIR PRIMARY CARE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492231 ASPIRATING SYRINGE TYPE CW SYRINGE EJI J & J INSTRUMENTS, LLC 100-9808 0522A 00304040004456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown