BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER/CRUSHER, PILL, BLUE

    MDR report key: 21847882 · Received April 16, 2025

    Report

    Report Number
    21847882
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 11, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ELEMENTS HAVE BLANK DATA: [DEVICE MODEL #:] FOR TYPE OF DEVICE: PILL CRUSHER/CUTTER. [DEVICE IDENTIFIER (DI):] FOR TYPE OF DEVICE: PILL CRUSHER/CUTTER. [DEVICE CATALOG (REF) #:] FOR TYPE OF DEVICE: PILL CRUSHER/CUTTER.

    Description of Event or Problem · 0

    [SITUATION]: THE NEWLY STOCKED PILL CRUSHER IS LEAVING PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS. B [BACKGROUND]: A FORMERLY STOCKED COMBO PILL CRUSHER/SPLITTER LEFT PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS. [ASSESSMENT]: PATIENT SAFETY IS AT RISK. THE SHREDS OF PLASTIC ARE NOT EASILY REMOVED FROM THE CRUSHED DOSE. IN ADDITION, DOSE MAY BE LOST TO PLASTIC REMOVAL. [RECOMMENDATION]: RUSH ORDER OF 5 SILENT KNIGHTS, 1 PER OMNICELL ALCOVE FOR EACH INPATIENT REGION. ORG-LEVEL PURCHASE OF SILENT KNIGHT CRUSHERS FOR EACH PATIENT ROOM SINCE PILL CRUSHING IS A HOUSE-WIDE NEED. WITH PHARMACY SUPPORT, EXPLORATION OF COMMUNITY RESOURCES FOR PILL CRUSHING AT HOME SINCE THE PRACTICE IS OFTEN AFFIRMED AT DISCHARGE. RECOUP OF ANY COSTS FROM PRODUCT SUPPLIER AS TWO PRODUCT OPTIONS HAVE NOW PROVEN DEFECTIVE AND UNSAFE.

    Description of Event or Problem · 0

    S [SITUATION]: THE NEWLY STOCKED PILL CRUSHER IS LEAVING PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS. B [BACKGROUND]: A FORMERLY STOCKED COMBO PILL CRUSHER/SPLITTER LEFT PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS A [ASSESSMENT]: PATIENT SAFETY IS AT RISK. THE SHREDS OF PLASTIC ARE NOT EASILY REMOVED FROM THE CRUSHED DOSE. IN ADDITION, DOSE MAY BE LOST TO PLASTIC REMOVAL. R [RECOMMENDATION]: RUSH ORDER OF 5 SILENT KNIGHTS, 1 PER OMNICELL ALCOVE FOR EACH INPATIENT REGION. ORG-LEVEL PURCHASE OF SILENT KNIGHT CRUSHERS FOR EACH PATIENT ROOM SINCE PILL CRUSHING IS A HOUSE-WIDE NEED. WITH PHARMACY SUPPORT, EXPLORATION OF COMMUNITY RESOURCES FOR PILL CRUSHING AT HOME SINCE THE PRACTICE IS OFTEN AFFIRMED AT DISCHARGE. RECOUP OF ANY COSTS FROM PRODUCT SUPPLIER AS TWO PRODUCT OPTIONS HAVE NOW PROVEN DEFECTIVE AND UNSAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122488 CUTTER/CRUSHER, PILL, BLUE PILL CRUSHER/CUTTER OHY MEDLINE INDUSTRIES, INC. NON137000R 13524080029

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male