BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-STATE PRO-PLUS ADVANTAGE

    MDR report key: 279026 · Received May 22, 2000

    Report

    Report Number
    MW1018958
    Event Type
    Injury
    Date Received
    May 22, 2000
    Report Date
    May 15, 2000
    Manufacturer
    TRI-STATE DISTRIBUTION
    Product Code
    LDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POTENTIAL DEFECT WITH THE STYLE OF CHILD-RESISTANT SAFETY CAPS USED ON ALL SIZE VIALS. THE VIALS IN QUESTION ARE THE PRO-PLUS ADVANTAGE PRESCRIPTION VIALS. THERE HAVE BEEN 3 INSTANCES OF SMALL CHILDREN OPENING THESE VIALS. TWO REQUIRED VISITS TO A LOCAL ER FOR BLOOD LEVELS AND OBSERVATION. THE OTHER REQUIRED OVERNIGHT HOSPITALIZATION FOR OBSERVATION. THE CHILDREN RANGED FROM 8 MOS - 3 YRS OF AGE. THE MEDICATIONS INVOLVED INCLUDED AMITRIPTYLINE, NORTRIPTYLINE, AND TYLENOL W/CODEINE 30 MG (EG) TABS. ALL HAD POTENTIAL FOR SERIOUS HARM OR DEATH TO PTS. THE CHILD-RESISTANT CAPS ARE RELATIVELY EASY TO OPEN WITHOUT HAVING TO PUSH DOWN AND TWIST CAP. EVEN WHEN CAP IS FASTENED TIGHTLY, A SMALL CHILD COULD PROBABLY OPEN THE BOTTLE. THE OTHER ISSUE IS THE OUTER SAFETY RING OF THE CAP CAN BE SEPARATED FROM THE INNER NON-SAFETY PORTION OF THE TOP WITH RELATIVELY LITTLE EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-STATE PRO-PLUS ADVANTAGE PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES) LDQ TRI-STATE DISTRIBUTION TS-PRO 11C *
    2 TRI-STATE PRO-PLUS ADVANTAGE PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES) LDQ TRI-STATE HOSPITAL SUPPLY CORP. TS-PRO 16C *
    3 TRI-STATE PRO-PLUS ADVANTAGE PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES) LDQ TRI-STATE HOSP SUPPLY CORP. TS-PRO 30C *
    4 TRI-STATE PRO-PLUS ADVANTAGE PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES) LDQ TRI-STATE HOSPITAL SUPPLY CORP. TS-PRO 40C *
    5 TRI-STATE PRO-PLUS ADVANTAGE PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES) LDQ TRI-STATE HOSPITAL SUPPLY CORP. TS-PRO 60C *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization