BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOJECT FLEXIBLE FORMULATION TIP CAP

    MDR report key: 398610 · Received June 6, 2002

    Report

    Report Number
    MW1025254
    Event Type
    Injury
    Date Received
    June 6, 2002
    Date of Event
    June 6, 2002
    Report Date
    June 6, 2002
    Manufacturer
    SHERWOOD MEDICAL
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FLEXIBLE FORMULATION TIP CAP FOR LUER LOCK SYRINGES. QUANTITY 10 INDIVIDUAL TIP CAPS (POLYOLEFIN). PRODUCT WAS FOUND TO HAVE A DECREASED INSECT WITHIN THE STERILE WRAP PACKAGING FOR A UNIT PACKAGE OF 10 INDIVIDUAL TIP CAPS. INAPPROPRIATE FOR USE DUE TO CONTAMINATION/COMPROMISE OF PRODUCT. PRODUCT ALSO HAS THESE NUMBERS PRINTED ON BACK:5300360, 006-1089, RPTR ASKS IF TOTAL LOT INAPPROPRIATE FOR USE OR JUST THIS UNIT OF 10 CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT FLEXIBLE FORMULATION TIP CAP SYRINGE CAP FMF SHERWOOD MEDICAL * 134800028-B

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention