BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50-60ML L/L NO NEEDLE

    MDR report key: 23415730 · Received October 29, 2025

    Report

    Report Number
    MW5178184
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT NEEDS EXTRA SYRINGE 50-60ML AND CADD EXT SET AS PT REPORTED THAT ABOUT 4 MONTHS AGO HE HAD DEFECTIVE SUPPLIES AND HAS OCCASIONALLY DROPPED SOME SUPPLIES ON THE FLOOR AND WOULD LIKE TO REPLENISH THAT SUPPLY. NO ADDITIONAL INFORMATION OR DETAILS AVAILABLE. " DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? NO; " DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; " " IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES, UPON RETURN " DID WE REPLACE DEVICE? YES; " DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; " IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; " IS THE INFUSION LIFE-SUSTAINING? YES"; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541090 SYRINGE 50-60ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male BOSENTAN.| REMODULIN MDV.| STERILE DILUENT. | TADALAFIL.