BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONSTERILE AMBER ENFIT SYRINGE

    MDR report key: 19918963 · Received August 5, 2024

    Report

    Report Number
    MW5158033
    Event Type
    Other
    Date Received
    August 5, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    PNR
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    STAFF REPORT THAT MEDLINE NONSTERILE AMBER ENFIT SYRINGES RECENTLY RECEIVED HAVE A NEW CAP THAT DOES NOT STAY ON THE SYRINGE VERY WELL. THE PREVIOUS CAP SCREWED ON AND IS MUCH LESS LIKELY TO POP OFF. CONTRIBUTING FACTORS: DISPENSING DEVICE INVOLVED MANUFACTURER PRODUCT QUALITY ISSUE. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. ISMP, (B)(4). SUBMISSION ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342879 NONSTERILE AMBER ENFIT SYRINGE ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS PNR MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown